Direct drive endoscopy systems and methods

ABSTRACT

Disclosed herein are various systems and methods for facilitating control of a tool or tools. The systems can allow a user to control multiple degrees of freedom. One such system allows a user to control multiple degrees of freedom of two tools simultaneously. Another such system allows a user to control multiple degrees of freedom with a single hand. Frames and rails for supporting and/or constraining movement of a tool or tools are also described herein.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to Provisional Application Ser. No.60/872,155 entitled “Systems and Methods For Intraluminal Surgery” filedDec. 1, 2006 and to Provisional Application Ser. No. 60/909,219 entitled“Direct Drive Endoscopy Systems and Methods” filed Mar. 30, 2007, bothof which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

Minimally invasive surgical tools, such as endoscopic and laparoscopicdevices, can provide surgical access to surgical sites while minimizingpatient trauma. Although the growing capabilities of such therapeuticdevices allow physicians to perform an increasing variety of surgeriesthrough traditional minimally invasive routes, further refinements mayallow surgical access through even less invasive routes. Currently somerobotic systems have been proposed to allow surgical access via anatural orifice. The user interface is remote from surgical tools and/orend effectors. Unfortunately, these systems are generally expensive andcomplicated. In addition, they fail to provide the tactile user feedbackwhich traditional devices can provide.

Accordingly, there is room for further refinement to conventionalminimally invasive surgical devices and a need to develop new surgicalsystems.

SUMMARY OF THE INVENTION

Described herein are various systems and methods for driving tools. Thetools, in one aspect, can be driven via user input forces that aredelivered to a distal working area. The tools and/or other elements ofthe various systems described below, in response to user input forces,can move in multiple degrees of freedom. The systems described hereincan also facilitate control of those multiple degrees of freedom. Forexample, multiple degrees of freedom can be actuated with only one hand.

In one embodiment, a system is provided which includes a guide tube forinsertion through a natural orifice. The guide tube can include at leastone channel therein for delivering a surgical instrument. In one aspect,multiple surgical instruments can be delivered through one or morechannels in the guide tube. The guide tube can provide at least onedegree of freedom to the system, and in another embodiment, can providemultiple degrees of freedom.

In one aspect, the guide tube can receive a flexible endoscope, or othervisualization means, to allow visualization of a surgical site. Inanother aspect, the guide tube can receive tools for tissue repair,evaluation, and/or resection. The endoscope, guide tube, and/or toolscan provide additional degrees of freedom to the system. For example,the tools can provide at least one, and in an other aspect, two or more,degrees of freedoms via a hand control.

In another aspect, the guide tube, tools, and/or optical device can workwith a support frame. The frame, for example, can mate with the toolsand assist with controlling additional degrees of freedom. In addition,the frame can define an ergonomic work area for a surgeon, as well as,provide a reference with respect to a patient.

Further described herein is a method of accessing a surgical site. Inone embodiment, a guide tube can be directed through a natural orificeto a surgical site. An optical device and at least one surgical tool canbe delivered to the surgical site through a channel in the guide tube. Auser can then view and manipulate a tissue mass via the optical deviceand the at least one surgical tool. In one aspect, the user can interactwith one or more controllers mated to a support frame as part ofactuating the at least one surgical tool.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a system describedherein.

FIG. 2A is a cross-sectional view of FIG. 1 along A-A.

FIG. 2B is another embodiment of a cross-sectional view of FIG. 1 alongA-A.

FIG. 3A is a disassembled view of a portion of the system of FIG. 1.

FIG. 3B is a cut-away view of a portion of the system of FIG. 1.

FIG. 4A is a cut-away view of a portion of the system of FIG. 1.

FIG. 4B is a cut-away view of a portion of the system of FIG. 1.

FIG. 5A is a front view of one exemplary element of the system describedherein.

FIG. 5B is a front view of another embodiment of the element of FIG. 5A.

FIG. 6A is a cross-sectional view of one exemplary embodiment of an endcap described herein.

FIG. 6B is another cross-section view of the end cap of FIG. 6A.

FIG. 7A is a perspective view of one exemplary embodiment of a channeldivider described herein.

FIG. 7B is a longitudinal cross-section of the channel divider of FIG.7A.

FIG. 7C is a perspective view of the channel divider of FIG. 7Apositioned within a guide tube.

FIG. 7D is a front view of one exemplary embodiment of a guide tubedescribed herein.

FIG. 7E is a side view of the guide tube of FIG. 7D.

FIG. 7F is a cross-sectional view of the guide tube of FIG. 7D.

FIG. 8 is a perspective view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 9A a transparent view of one exemplary embodiment of a guide tubedescribed herein.

FIG. 9B is a transparent front view of the guide tube of FIG. 9A.

FIG. 10A is a perspective view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 10B is a cross-section view of the system of FIG. 10A.

FIG. 11 is a perspective view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 12 is a perspective and partially transparent view of the distalend of one exemplary embodiment of a system described herein.

FIG. 13 is a side and partially transparent view of the distal end ofone exemplary embodiment of a system described herein.

FIG. 14 is a side view of the distal end of one exemplary embodiment ofa system described herein.

FIG. 15A is a side view of the distal end of one exemplary embodiment ofa system described herein.

FIG. 15B is a side view of the distal end of one exemplary embodiment ofa system described herein.

FIG. 16A is a cross-sectional view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 16B is another cross-sectional view of FIG. 16A.

FIG. 16C is another cross-sectional view of FIG. 16A.

FIG. 16D is a side view of FIG. 16A.

FIG. 17 is a perspective view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 18 is a perspective view of the distal end of another exemplaryembodiment of a system described herein.

FIG. 19A through 19C are perspective views of the distal end of oneexemplary embodiment of a system described herein.

FIG. 20 is a cross-sectional view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 21 is a cross-sectional view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 22 is a perspective view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 23 is a perspective view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 24 is a perspective view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 25 is a cross-sectional view of the distal end of one exemplaryembodiment of a system described herein.

FIGS. 26 and 27 are perspective views of the distal end of one exemplaryembodiment of a system described herein.

FIGS. 28A and 28B are cross-sectional views of the distal end of oneexemplary embodiment of a system described herein.

FIG. 29A is a partly transparent view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 29B is a front view of the distal end of one exemplary embodimentof a system described herein.

FIG. 30 is a perspective view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 31A is a perspective view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 31B is a transparent view of the distal end of one exemplaryembodiment of a system described herein.

FIGS. 32A and 32B are perspective views of the distal end of oneexemplary embodiment of a system described herein.

FIGS. 33A and 33B are partially transparent views of the distal end ofone exemplary embodiment of a system described herein.

FIG. 34 is a perspective view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 35 is a perspective view of the distal end of one exemplaryembodiment of a system described herein.

FIG. 36 is a perspective view of one exemplary embodiment of a guidetube described herein.

FIGS. 37 and 38 are partially disassembled views of one exemplaryembodiment of a guide tube described herein.

FIG. 39 is a perspective view of one exemplary embodiment of a systemdescribed herein.

FIGS. 40A and 40B are cross-sectional views of one exemplary embodimentof the proximal end of a working channel.

FIG. 40C is a perspective view of one exemplary embodiment of the distalend of a guide tube.

FIGS. 41A through 41C are various exemplary embodiments of rigid orpartially rigid guide tubes.

FIGS. 42A through 42C are perspective views of various exemplaryembodiments of a system described herein for laparoscopic procedures.

FIGS. 43A through 43I are perspective views of various guide tube andinstrument embodiments described herein.

FIG. 44 is a perspective view of one exemplary embodiment of a frame foruse with a system described herein.

FIG. 45 is a perspective view of one exemplary embodiment of a frame andguide tube for use with a system described herein.

FIG. 46 is a top view of one exemplary embodiment of a quick-disconnectfor use with the guide tubes and frames described herein.

FIG. 47 is a side view of one exemplary embodiment of a frame for usewith a system described herein.

FIG. 48 is a perspective view of one exemplary embodiment of a frame foruse with a system described herein.

FIG. 49 is a perspective view of one exemplary embodiment of a frame foruse with a system described herein.

FIG. 50 is a perspective view of one exemplary embodiment of a frame foruse with a system described herein.

FIG. 51 is a perspective view of one exemplary embodiment of a frame foruse with a system described herein.

FIG. 52 is a perspective view of one exemplary embodiment of a railmounted on an optical device.

FIG. 53 is a perspective view of one exemplary embodiment of a frame foruse with a system described herein.

FIG. 54 is a perspective view of one exemplary embodiment of rails foruse with a system described herein.

FIG. 55 is a side view of one exemplary embodiment of tool and rail foruse with a system described herein.

FIG. 56 is a side view of one exemplary embodiment of tool and rail foruse with a system described herein.

FIGS. 57 through 58B illustrate various exemplary quick-disconnects foruse with a system described herein.

FIGS. 59A through 59C illustrate various locking and/or damping elementsfor use with a system described herein.

FIGS. 60 and 61 are perspective views of exemplary features of tools andrails described herein.

FIG. 62A is a perspective view of one exemplary embodiment of a controlmember and rail described herein.

FIGS. 62B and 62C are cross-sectional view of exemplary features of acontrol member described herein.

FIGS. 63A through 65 are perspective views of various exemplary railsand tools described herein.

FIG. 66A is a partially transparent view of one exemplary embodiment ofa rail and tool described herein.

FIG. 66B is a cross-sectional view along B-B of FIG. 66A.

FIG. 67 is a perspective view of one exemplary embodiment of a controlmember and rail described herein.

FIG. 68A is a perspective view of one exemplary embodiment of a controlmember and rail described herein.

FIG. 68B is a perspective view of another exemplary embodiment of acontrol member and rail described herein.

FIGS. 69A and 69B are partially transparent views of various exemplaryembodiments of a control member and rail described herein.

FIG. 70 is a perspective view of another exemplary embodiment of acontrol member and rail described herein.

FIGS. 71A through 73 are various exemplary embodiments of a rail andguide tube described herein.

FIG. 74 is a perspective view of one exemplary embodiment of a systemdescribed herein.

FIGS. 75 through 79 are views of various exemplary features of thesystem of FIG. 74.

FIG. 80A is a perspective view of one exemplary tool described herein.

FIGS. 80B through 84 are various partially disassembled views of thetool of FIG. 80A.

FIGS. 85 through 89B are various partially transparent views ofexemplary control mechanism for use with a control member describedherein.

FIGS. 90 through 96 are various perspective views of exemplary handlesfor use with a control member described herein.

FIG. 97 is a perspective view of an exemplary embodiment of a capstanfor use with a tool described herein.

FIG. 98A is a perspective view of an exemplary control mechanismdescribed herein.

FIGS. 98B and 98C are cross sectional views of one exemplary element ofthe control mechanism of FIG. 98A.

FIGS. 99 and 101 are perspective views of exemplary control mechanismsdescribed herein.

FIG. 102 is a perspective view of an exemplary control member for usewith a system described herein.

FIG. 103 is a perspective view of foot pedals for use with a systemdescribed herein.

FIG. 104 is a partially transparent view of a control mechanism havingexemplary locking and/or damping mechanisms.

FIG. 105 is a partially transparent view of a control mechanism havingan exemplary locking and/or damping mechanism.

FIG. 106 is a partially transparent view of one exemplary embodiment ofa tool and rail described herein.

FIG. 107 is a side view of one exemplary embodiment of a tool and raildescribed herein.

FIG. 108 is a perspective view of one exemplary embodiment of aninstrument described herein.

FIG. 109 is a cut-away view of one exemplary embodiment of a tooldescribed herein.

FIG. 110 is a cut-away view of another exemplary embodiment of a tooldescribed herein.

FIGS. 111A through 111C are partially transparent views of exemplary endeffectors described herein.

FIG. 112 is perspective view of the distal end of one exemplaryembodiment of a tool described herein.

FIGS. 113A and 113B are perspective views of various exemplary elementsof a tool described herein.

FIGS. 114 through 116B are partially transparent views of exemplaryembodiments of tools described herein.

FIG. 117 is perspective view of the distal end of one exemplaryembodiment of a tool described herein.

FIG. 118 is perspective view of the distal end of one exemplaryembodiment of a tool described herein.

FIGS. 119A and 119B are perspective views of an exemplary embodiment ofa tool described herein.

FIG. 120A is a disassembled view of one exemplary embodiment of a toolsdescribed herein.

FIG. 120B is a cross-sectional view of the tool of FIG. 120A.

FIGS. 121A and 121B are front and cross-sectional views of an exemplaryelement of the tool of FIG. 102A.

FIG. 122A is a cut-away view of one exemplary embodiment of a two-parttool described herein.

FIG. 122B is a perspective view of the tool of FIG. 122A.

FIGS. 123A through 123D are cross-sectional view of exemplaryembodiments of a tool described herein.

FIG. 124 is a perspective view of one exemplary embodiment of a tooldescribed herein.

FIGS. 125A through 125C are partial cross-sectional views of exemplaryembodiments of a two-part tool described herein.

FIGS. 126 though 130 are side views of exemplary embodiments ofdisposable elements of tools described herein.

FIGS. 131A through 131J are perspective views of exemplary steps of knottying using a system described herein.

DETAILED DESCRIPTION

Disclosed herein are systems and methods for performing surgery at adistance via medical instruments directly connected to user controls. Inone aspect, the system is adapted for trans-oral, trans-anal,trans-vaginal, trans-urethral, trans-nasal, transluminal, laparoscopic,thorascopic, orthopedic, through the ear, and/or percutaneous access.

Various exemplary components of the system are described below in moredetail. However, generally, the system can include at least oneinstrument directly connected to a user control. The system can permit auser to control at least two degrees of freedom via a controller thatcan be manipulated with a single hand. In another aspect, thesingle-hand controller can control three, four, or more than fourdegrees of freedom. In yet another aspect, at least two controllers,each configured for single-hand control, are provided. Each controllercan provide at least two degrees of freedom, three degrees of freedom,four degrees of freedom, or more than four degrees of freedom. In orderto allow the user to manipulate the multiple degrees of freedom, thesystems can include a structure that provides a frame of referencebetween the user, the instruments, the controllers, and/or the patient.This structure can be provided by a variety of different components asdescribed below.

The following disclosure is broken into several sections, including adescription of a guide tube for housing a portion of an instrument orinstruments, a frame, rails which can facilitate instrument movement, acontroller for manipulating the instrument or instruments, and theinstruments themselves. It should be appreciated that the systemsdescribed and claimed herein can include any or all of the variousdisclosed components and the various embodiments of those components. Inaddition, a single structure can define and/or perform the function ofelements described in two separate sections of the disclosure. Forexample, the frame or guide tube can define a rail. A portion of thedisclosure is directed to exemplary systems (e.g., FIG. 1), but itshould be understood that this invention is not limited to thoseexemplary systems.

In addition, while the discussion of systems and methods below maygenerally refer to “surgical tools,” “surgery,” or a “surgical site” forconvenience, the described systems and their methods of use are notlimited to tissue resection and/or repair. In particular, the describedsystems can be used for inspection and diagnosis in addition, or as analternative, to surgery. Moreover, the systems describe herein canperform non-medical applications such as in the inspection and/or repairof machinery.

FIG. 1 provides a perspective view of one embodiment of a system 20 forperforming intraluminal and/or transluminal surgery through a naturalorifice. The system includes a frame 22 for supporting control members24 a, 24 b, of tools 40 a, 40 b, and a guide tube 26 for housing theelongate body of tools 40 a, 40 b, and/or an optical device 28. When theguide tube 26 is inserted into a patient, control members 24 a, 24 ballow a surgeon to manipulate surgical tools 40 a, 40 b which extend toa surgical site positioned adjacent to the distal end 34 of guide tube26. As will be described in more detail below, frame 22 can have avariety of configurations depending on patient location, spacing,ergonomics, physician preference, and/or the availability of anoperating table frame.

The Guide Tube

Guide tube 26 can have an elongate body 32 extending from the frame andconfigured for insertion through a natural orifice and/or incision to asurgical site within a patient. While the guide tube is shown in FIG. 1as mated with frame 22, guide tube 26 can be used without frame 22during a portion or all of a surgical procedure. In one aspect, guidetube 26 includes a distal articulating end 34 that is controlled byproximal guide tube controls 30. A proximal end 36 of the guide tube caninclude at least one aperture for receipt of surgical instruments, suchas, for example, tools 40 a, 40 b and/or optical device 28 (togethergenerally referred to herein as “surgical instruments”). Betweenproximal end 36 and distal end 34 of guide tube 26, elongate body 32 caninclude a mid-portion 33. In one embodiment, mid-portion 33 is generallyflexible and non-articulating. In another embodiment, at least a portionof the guide tube is rigid. For example, a portion or the whole of guidetube 26 can be rigid.

In one embodiment, as discussed below, guide tube 26 can provide system20 with one, two, or more than two degrees of freedom. For example,guide tube 26 can be articulated with controls 30 to move at least aportion of guide tube 26 (e.g., distal end 34) up/down and/orside-to-side. Additional degrees of freedom, provided for example, viarotation, translational movement of the guide tube with respect to theframe, and/or additional articulation or bending sections, are alsocontemplated.

The outer surface of elongate body 32 of guide tube 26 can include alayer of lubricous material to facilitate insertion of guide tube 26through a body lumen or surgical insertion. The interior of elongatebody 32 can include at least one channel adapted to guide at least oneelongate surgical instrument to a surgical site. In another aspect, thebody can have two channels, three channels, or more than three channels.In one aspect, the guide tube includes multiple channels comprising amain channel for receipt of an optical device, such as an endoscope, andworking channels for receipt of articulating surgical tools. The numberof channels and their particular configuration can be varied dependingon the intended use of the system and the resultant number and type ofsurgical instruments required during a procedure. For example, the guidetube can include a single channel adapted to receive multipleinstruments or multiple channels for multiple instruments.

FIGS. 2A and 2B illustrate exemplary cross-sectional views of themid-portion of elongate body 32 (taken along line A-A in FIG. 1) thatincludes main channel 42 and working channels 44 a, 44 b. While threechannels are illustrated, fewer channels (e.g., one or two) or morechannels (e.g., four or more) are also contemplated. In addition, whilemain channel 42 is described as the largest channel, in terms ofcross-sectional width, the working channels 44 a, 44 b can be a largeror smaller size than main channel 43. Moreover, use of the word“channel” does not require that the optical devices and/or surgicalinstruments traversing the guide tube be distinct or stand alonedevices. For example, in one embodiment, the system includes an opticaldevice and/or surgical instrument formed integrally with the guide tube.In still another embodiment, the optical devices and/or instrumentsdescribed herein can, themselves, define the guide tube. For example,the optical device can define the guide tube and include channels forinstruments.

Regardless, in the exemplary illustrated embodiment of FIG. 2A, mainchannel 42 can be defined by at least one elongate lumen that extends,at least partially, between proximal and distal ends 36, 34 of guidetube 26. Similarly, working channels 44 a, 44 b can be defined byseparate lumens, with main and working channels housed in an outerlumen. Alternatively, as illustrated in FIG. 2B, at least one ofchannels 42, 44 a, 44 b, can be defined by a divider that extend alongat least a portion of guide tube 26. For example, all three channels 42,44 a, 44 b can share a common sheath or outer jacket 54. One skilled inthe art will appreciate that the divider can be defined by a portion ofthe guide tube and/or by a separate element that is mated with the guidetube and/or instruments (an example of which is described in more detailwith respect to FIGS. 7A through 7C).

Referring now to FIG. 2A, in one aspect, main channel 42 comprises aninner tubular body 46 and an outer tubular body 48. Both the inner andouter tubular bodies can comprise flexible materials. In one aspect,inner tubular body 46 has a lubricous inner surface. For example, innertubular body 46 can be formed from a low friction material such as afluoropolymer (e.g., polytetrafluoroethylene). Alternatively, innertubular body can defined by a coating of low friction material.

In order to improve the flexible characteristics of the inner tubularbody, the inner tubular body can have a configuration that reduces therisk of kinking or narrowing the tubular body and/or that increases thebend angle of the guide tube. In one aspect, the inner tubular body isspiral cut to provide open sections of inner tubular body 46. Forexample, the spiral cut tube can result in windings with open sectionsbetween the windings, such that the windings can move toward and awayfrom each other when the guide tube bends. One skilled in the art willappreciate that the materials and construction of the inner tubular bodycan be chosen to meet the desired flexibility of the guide tube. Inaddition, the inner tubular body can include different materials and/orconfigurations along the length of the guide tube to provide varyingflexibility along the length of the guide tube.

Where the inner tubular body has a spiral cut or “open” configuration,the main channel can further be defined by outer tubular body 48. Theouter tubular body of the main channel can provide structure to thespiral cut inner tubular body and limit the amount of play between thewindings of the spiral cut tubular body. The outer tubular body can beformed from a variety of flexible materials including polymers and/ormetals. In addition, outer tubular body 48 can include reinforcingmaterials to further strengthen the main channel, such as, for example,a mesh and/or braid. In one aspect, the wall of the outer tubular bodyof the main channel does not have any perforations or openings to theadjacent environment. For example, the outer tubular body can beimpervious and provide a fluid barrier.

The working channels 44 a, 44 b can have a similar or differentconfiguration from the main channel and from each other, including, forexample, one, two, or more than two coaxial tubular bodies. In addition,working channels 44 a, 44 b can extend for all or a part of the lengthof the guide tube. In one aspect, the working channels include alubricious material that coats or defines a working channel tubularbody. As shown in FIG. 2A, the working channels 44 a, 44 b, in oneembodiment, includes single tubular bodies 50 a, 50 b formed of afluoropolymer. In addition, the working channel tubular bodies 50 a, 50b can include reinforcing materials 51 (FIG. 3A), such as, for example,a mesh, spiral, and/or braid. Regardless of the configuration of thechannels 44 a, 44 b, the inner walls of the working channel bodies 50 a,50 b can be lubricous. For example, a lubricous coating, film, paste, orfluid and/or secondary material (liner) can be use to facilitateinsertion of a tool or optical device through the channels.Additionally, or alternatively, the inner and/or outer surfaces of theguide tube can have raised surface features, such as, for example ribs,to reduce friction.

In another embodiment, one or more of the channels (e.g., main and/orworking channels) can be formed from walls comprising a loose orstretchable material (not illustrated), such as an accordion-typematerial having folds and/or a loose bag type-liner. The folds in thewalls of the channel allow longitudinal expansion and contraction ofportions of the channel. The loose material can have a partially foldedconfiguration such that when the channel bends, the folds open to allowexpansion of a portion of the channel wall. In another aspect, the wallsof one or more of the channels are configured to allow stretching orexpanding.

In still another embodiment, a single member defines two or more of thechannels (e.g., main and/or working channels). For example, workingchannels 44 a, 44 b, can be defined by co-extruded lumens.Alternatively, or additionally, the multiple layers than define achannel (e.g., inner and outer tubular bodies 46, 48) could beco-extruded.

With respect to FIG. 3A, In one aspect, the working and main channelsare not fixedly mated to one another. Instead, a mesh, spiral, jacket,and/or filament braid 52 can cinch the channels together and keep thechannels bundled together. Depending on the desired rigidity of themid-portion of the guide tube, the mesh density, rigidity, and materialsof braid 52 can be varied. In an alternative aspect, filaments, bands,or other place holders can be positioned around two or more of thechannels to limit transverse movement of the channels away from oneanother. In still another aspect, the guide tube does not includes anyconnection between the channels.

The guide tube can further include an outer jacket 54 surrounding thechannels. The outer jacket can work with, or take the place of, filamentbraid 52 and assist with bundling the main and working channelstogether. In one aspect, the outer jacket is formed of a continuous,fluid impermeable material that acts as a barrier against the intrusionof biological material into the guide tube. In use, as mentioned above,the guide tube can be inserted through a body orifice and the outerjacket can provide a barrier to bacteria found along a body pathway. Inone aspect, the outer jacket is formed of an elastomeric and/orpolymeric material such as, for example, PTFE, EPTFE, silicon, urethane,and/or vinyl.

In addition to protecting the inner channels, the outer jacket can havea lubricous outer surface to assist with insertion of the guide tube.The lubricous surface can minimize tissue trauma and help to ease thedevice through a body lumen.

In one aspect, the guide tube can include variable stiffness along itslength. For example, the material properties of the various layers ofguide tube 26 can be varied to control the stiffness of the guide tube.In addition, or alternatively, stiffeners can be located in areas inwhich increased stiffness is desired. One skilled in the art willappreciate the degree of stiffness can be chosen depending on theintended use of system 20. In addition, the stiffness of guide tube 26can be controlled by the user. For example, the guide tube can have alocking configuration. Once the guide tube is positioned within apatient, the user can lock the guide tube in position.

In addition, while the guide tube channels are illustrated as enclosedand protected from the environment surrounding the guide tube, in onealternative aspect, at least one of the guide tube channels can have anopen configuration. For example, the main channel can be defined by anopen or split wall lumen such that a instrument can be inserted into theguide channel through the sidewall of the guide tube. Instead ofinserting the instrument through the proximal opening of the guide tube,the optical device can be inserted into the working channel through thesidewall of the guide tube. In one such aspect, a snap-fit orinterference fit can hold the instrument in the main channel.

Distal to the mid-portion 33 of elongate body 32, the guide tube caninclude an articulation portion 56 (FIG. 1). In one aspect, thearticulation portion provides at least one degree of freedom, and inanother aspect, provides more than one degree of freedom (e.g., two,three, or more than three degrees of freedom) to system 20. Inparticular, the distal end of the guide tube can be moved side-to-sideand/or up/down by the proximal controls 30. In another aspect, the guidetube can additionally, or alternatively, move longitudinally and/orrotate. Articulation, regardless of the number of degrees of freedom,can be controlled in a variety ways and is discussed in more detailbelow.

In one aspect, the main channel is adapted to articulate while theworking channels are mated to the main channel and move with the mainchannel. In other words, the working channels are not directlyarticulated. However, in another aspect, all the channels can bedirectly articulated together or independently depending on the intendeduse of system 20. Another embodiment includes a single lumen thatarticulates and is configured to receive multiple instruments ormultiple channel bodies. For example, the guide tube can include oneworking channel for receiving multiple instruments.

FIGS. 3A through 4B illustrate one embodiment of the transition betweenmid-portion 33 and articulation portion 56. FIGS. 3A and 3B illustrate adisassembled view and partially disassembled (outer sheath removed) viewof the articulation portion of the exemplary guide tube, while FIG. 4Aillustrates a partially transparent view of the articulation portionwith various layers removed. FIG. 4B illustrates the distal-most end ofthe articulation portion with outer sheath 54 removed. As shown in FIGS.3A through 4A, the working channel bodies 50 a, 50 b extend through thearticulation portion 56 of guide tube 26, while the inner and outertubular bodies 46, 48 end at articulation portion 56. The main channel42 in the articulation portion 56 of guide tube 26 can be defined by anarticulation body member 58 having an inner lumen. In addition, theworking channel bodies in the articulation section can have a differentconfiguration from the working channel bodies in the mid-portion of theguide tube. For example, in the mid-portion 33 of guide tube 26, workingchannel bodies 50 a, 50 b can include a reinforcing braid or winding 51.Conversely, as shown in FIGS. 3A, 3B and 4A, the working channel bodies50 a, 50 b do not include a reinforcing braid or winding 51 in thearticulation portion 56.

A variety of control mechanisms can be used to manipulate thearticulation portion, including, for example, push-pull strands, leafsprings, cables, oversheaths, ribbons, electroactive materials, and/orfluid actuation.

In one embodiment, strands 60 extend from the proximal portion of theguide tube to the articulation body member 58 to control thearticulation body member. Strands 60 can comprise one or more filamentsformed of a flexible material including, for example, a variety of wiresand cables. In one aspect, strands 60 include an inner filamentpositioned within an outer casing. For example, strands 60 can bedefined by bowden cables which reduce power losses along the length ofthe guide tube.

As shown in FIGS. 3A and 4A, four strands 60 can extend to thearticulation portion 56 and provide two degrees of freedom guide tube26. When tensioned, the strands can bend the articulation body 58 bymoving a series of articulation segments 62. The articulation segments62 together define the articulation body 58 and the main channel 42 inthe articulation portion 56 of the guide tube 26. In one aspect, springs64 connect the articulation segments 62 and allow the articulationsegments to move relative to one another. Strands 60 extend across thearticulation portion and mate with a distal articulation segment 62′.When a strand is tensioned, the articulation segments 62 move relativeto one another along at least part of the articulation portion 56 of theguide tube to allow articulation portion 56 to bend.

Strands 60 can mate with articulation body member 58 in a variety ofways. In one aspect, the ends of the strands are welded to the innersurface of the articulation body member 58. Alternatively, as shown inFIGS. 3A and 4A, the distal end of the strands can include terminals 59which mechanically engage loops attached to, or formed on, the innersurface of the articulation body member. Terminals 59 can have a largerouter diameter than the inner diameter of the loops, such that theterminals cannot be pulled proximally through the loops.

FIG. 5A illustrates loops 61 welded to the interior of guide tube 26proximate to the distal end of the guide tube (i.e., proximate to thedistal end of articulating body member 58) for mating with the distalends of strands 60. In another aspect, shown in FIG. 5B, guide tube 26can include a mating plate 63 having apertures 65 for receiving strands60 and preventing the passage of terminals 59. Mating plate 63 candefine the location and spacing apertures 65, which can eliminate thedifficult process of carefully spacing, aligning, and mating individualloops to the inner surface of the articulation body member. In addition,mating plate 63 can include one or more apertures for the passage ofchannels 42 and/or 44 a, 44 b. In one aspect, mating plate 63 is matedto the distal end of articulation body member 58 via welding, adhering,mechanical interlock, and/or frictional engagement.

The mating plate can also serve to align and space a surgical instrument(e.g., an optical device), extending through the articulation section56, from the walls of the articulation section and/or from anotherinstrument. In one aspect, the working channel aperture 42 within themating plate can align the a surgical instrument with the center of thearticulation section. In addition, or alternatively, the location of theworking channel aperture can space an optical device passing therethoughfrom the inner surface of the articulation section. The mating plate caninhibit contact between a surgical instrument and the inner surfaces ofthe articulation section (e.g., springs).

To prevent articulation segments 62 from binding, pinching, and/orpiercing the outer jacket 54, an articulation body member mesh or braid68 (FIGS. 3B, and 4A) can extend over the articulation body member 58.The articulation body member mesh or braid 68 can be the same ordifferent from the mesh or braid 52 found in the mid-portion 33 ofelongate body 32. As shown in FIGS. 3B and 4A, the articulation bodymember mesh or braid 68 extends over articulation body member 58, butnot over the adjacent working channel bodies 50 a, 50 b. Alternatively,the mesh or braid 58 can enclose more than one channel.

The degree to which the articulation portion bends can be varied byadjusting the shape of the articulation segments and/or the distancebetween the articulation segments. In one aspect, the articulationportion can bend up to about at least 180 degrees to allow retroflexing.For example, in a trans-oral approach to a gall bladder or liver, asurgeon may wish to turn in a cranial direction to look toward thediaphragm. Other procedures may require less bend, such as, for example,a bend of at least about 45 degrees from the longitudinal axis of theguide tube. Exemplary configurations of guide tube 26 with feature fordirecting surgical instruments along an increased bend, includingretro-flexing, are described below. In addition, or alternatively, theguide tube can include multiple bending sections and/or can be adaptedto lock in position or increase in stiffness.

As the articulation portion 56 bends, the articulation body member 58and the working channel bodies 50 bend over different arcs. As a result,the working channel bodies 50 a, 50 b can move or side longitudinallyrelative to the articulation body member 58. In order to keep thearticulation body member 58 and the working channel bodies 50 bundled,the articulation body member and the working channel bodies 50 can beheld together with a place holder that allows relative longitudinalmovement, while restricting relative transverse movement of thechannels. In one aspect, as shown in FIGS. 3A through 4B, the placeholder can include a rigid strap 70 extending around the articulationbody member 58 and the working channel bodies 50. Strap 70 can inhibitrelative transverse movement of the articulation body member and theworking channel bodies while allowing the articulation body member andthe working channel bodies to move longitudinally with respect to oneanother. In one aspect, the articulation portion 56 includes multipleplace holders, such as multiple straps, along its length. One skilled inthe art will appreciate that the place holder could be defined by avariety of elements that maintain the cross-sectional relationship ofthe channels.

At the distal end of the guide tube, system 20 can include an end cap 80(FIGS. 3B and 4B) that provides openings through which surgical toolscan pass from the channels of the guide tube into a working space withina patient. As mentioned above, when the articulation portion bends, thearticulation body member (defining the main channel) and the workingchannel bodies (defining the working channels) move relative to oneanother. In one aspect, the articulation body member 58 is fixedly matedto the end cap, while the working channel bodies 50 are allowed to movelongitudinally within end cap 80. For example, the end cap can provide aspace for the distal ends of the working channel bodies 50 to moverelative to the articulation body member 58 and the end cap 80. FIGS. 6Aand 6B illustrate cross-sectional views of end cap 80 with thearticulation portion mated with the end cap and a working passageway 82a that receive working channel body 50 a (Working channel body 50 b andworking passageway 82 b are hidden in FIGS. 6A and 6B. The secondworking passageway 82 b is illustrated in FIG. 4B). As shown in FIG. 6A,as the articulation portion bends in the direction of the main channel42, working body 50 a withdraws from end cap 80. Conversely, as shown inFIG. 6B, as the articulation portion bends toward the working channels,working channel body 50 b move into the end cap relative to the mainchannel.

In another embodiment, at least one channel (e.g., the working channelbodies) in the articulation section of the guide tube can be formed of aloose or stretchable material. For example, the wall of bodies 50 a, 50b can be formed from a loose or stretchable material (not illustrated),such as an accordion-type material having folds or billows. The loosematerial can allow longitudinal expansion and/or contraction to reduceor eliminate the impact of relative longitudinal movement of thechannels in the articulation section.

The end cap can be mated to one or more of the articulation segments 62and/or mating plate 63. For example, end cap 80 and articulation bodymember 58 can mate via welding, adhering, mechanical interlock, and/orfrictional engagement. Conversely, the working channel bodies 50 a, 50 bcan move freely within the working passageways 82 a, 82 b within end cap80. To prevent working channel bodies 50 a, 50 b from backing out of theproximal opening of passageways 82 a, 82 b, passageways 82 a, 82 b canhave a sufficient length such that working channels bodies remain withinthe end cap passageways even when the articulation portion is at itsfull bend limit. In addition, while two passageways 82 a, 82 b aredisclosed for two working channel bodies 50 a, 50 b, in another aspect,a single passageway could receive two or more working channel bodies.

In another aspect, end cap 80 and or working channel tubular bodies 50a, 50 b can be configured to prevent the distal ends of the workingchannel bodies 50 a, 50 b from exiting the proximal and/or distalopenings of working passageways 82 a, 82 b. For example, the distal endsof the working channel bodies 50 a, 50 b can have an outer diameter thatis larger than the inner diameter of the proximal and/or distal openingsto the working passageways 82 a, 82 b in end cap 80. In another aspect,the working channel bodies can include stops (not illustrated) toprevent the working channel bodies from fully withdrawing from theproximal end of end cap 80. For example, the working channel tubularbodies can include a stop formed of resilient material that can becompressed to insert the distal ends of the working channel bodies intothe end cap. Once inserted, the stop can expand such that the stop has alarger diameter than the proximal opening of working passageways 82 a,82 b in end cap 80. One skilled in the art will appreciate that thestops can have a variety of configurations to inhibit unwantedwithdrawal of the working channel tubular bodies 50 a, 50 b from theproximal and/or distal end of the working passageways of the end cap.

System 20 can further include a seal between the end cap and the end ofthe outer jacket 54. To assist with seating of the seal, as shown inFIGS. 3A, 3B, and 4B, the end cap can include a recess into which a seal86 can sit on the outer surface of the end cap. In one aspect, the endof the articulation portion can also include surface features tofacilitate seating of the seal. Seal 86 can have a variety ofconfigurations, and in one aspect, is formed of a heat shrinkablematerial that sits within a recess of end cap 80 and cinches around theouter surface of end cap 80 when shrunk.

The end cap can have a variety of shapes and sizes, and in particular,the distal surface of the end cap can be blunt to facilitate insertionof the guide tube through a body lumen while minimizing tissue trauma.For example, in one aspect, the end cap can have a taper to assist withmoving the guide tube through a body lumen. The end cap can be formed,at least in part, of radiological opaque material that allows a surgeonto visualize the end of the guide tube within a body lumen. For example,the end cap can include, for example, metals or radiopaque polymers. Inanother aspect, at least a portion of the end cap can be formed ofnon-radio opaque material such as for example, plastic or elastomermaterials. In yet another embodiment, the end cap is formed at least inpart by transparent or partially transparent material to allow a user toobserve a tool within a passageway of the end cap.

In another aspect, the guide tube end cap can include a flexible orresilient material for holding the various channels of the guide tube inposition with respect to one another. As the guide tube bends, theresilient material can permit elongation/compression of the channels andcan maintain the orientation of the lumens with respect to one another.In one aspect, articulation portion 56 can be defined by resilientmaterial, such as, for example, an extrusion having lumens defining theworking and main channels 44 a, 44 b, 42. The resilient articulationsection can be articulated via pull wires as described above.

In another embodiment of guide tube 26, the guide tube the main andworking channels are defined by a removable channel divider. With thechannel divider removed, a large instrument channel is opened for theinsertion of wider or larger tools. For example, a standard endoscopecan be inserted with the channel divider removed. The channel dividercan then be positioned within the large instrument channel to defineseveral smaller channels within the guide tube. In one aspect, thechannel divider defines the main and/or working channels.

FIG. 7A illustrates a channel divider 700 defining main channel 42 andworking channels 44 a, 44 b. Channel divider 700 can have an outer shapeand size that generally corresponds to a lumen within the guide tube.Inserting the channel divider into the guide tube lumen can mate thechannel divider and guide tube. For example, friction between the outersurface of the channel divider 700 and the inner surface of the guidetube can mate the channel divider and guide tube. In another aspect, theguide tube and/or channel divider can include mating features to lockthe channel divider within the guide tube and prevent relative movementbetween the channel divider and guide tube.

In one aspect, the passageways within channel divider 700 are enclosedby the body of the channel divider. Alternatively, as illustrated inFIG. 7A, the passageways can have an open or split side to allowinsertion of tools and/or optics through the sidewall of channel divider700.

FIGS. 7B and 7C illustrate channel divider 700 within guide tube 26. Inone embodiment, tools and/or optics can be loaded into the channeldivider prior to insertion of the channel divider into the guide tube.The channel divider, with tools positioned therein, can then be insertedinto the guide tube. In one aspect, channel divider 700 has a lengththat extends the majority of the length of the guide tube. In anotheraspect, multiple channel dividers can be provided.

Channel divider 700 can be formed of a variety of flexible,compressible, and/or resilient materials. Where a flexible guide tube orguide tube segment is desired, the channel divider can be formed ofsoft, flexible material. Conversely, where increased guide tubestiffness is desired, a harder, less flexible channel divider can beprovided. In one aspect, the material properties of the channel dividervary along its length to provide varying guide tube flexibility.

In another embodiment of guide tube 26, channels (working and/or main)and/or tools can mate with a central control shaft. For example, asillustrated in FIGS. 7D and 7E, central control shaft 750 mates withworking channels bodies 50 a, 50 b, 50 c, and 50 d defining workingchannels 44 a, 44 b, 44 c, and 44 d. The channel bodies can surroundshaft 750 and/or attach to the outer surface of shaft 750. In oneaspect, the channel bodies are exposed to the surrounding environmentand not enclosed by an outer tubular body. In particular, an outertubular body need not surround and/or constrain relative movement (e.g.,relative radial movement) of the channels. Instead a central shaft orshafts 750 can mate with and hold the channel bodies in positioned withrespect to one another.

Shaft 750 can also include an articulation section for steering thechannels. For example, control wires can extend through or along shaft750 to a distal articulation section. Tensioning the control wires candrive one or more degrees of freedom of shaft 750, including, forexample, up/down and/or left/right movement.

In one aspect, one or more of the channel bodies 50 a, 50 b, 50 c, and50 d fixedly mate with shaft 750. In another aspect, the channel bodiescan detachably mate with shaft 750. A user can select the desired typeof channel and/or the number of channels and attach the channel bodiesto shaft 750. In still another aspect, the channel bodies can be movablymated with shaft 750. For example, the shaft can act as a guide wire. Inuse, a clinician can direct the shaft to the desired location and thenmate the channel bodies with shaft 750. Moving the channel bodies alongthe shaft can delivery the channel bodies to the target area.Alternatively, the shaft and channel bodies can be delivered togetherand then the channel bodies can be moved relative to the central shaftto position the channels in a desired configuration.

FIG. 7F illustrates a cross-section of guide tube 26 showing channelbody 50 a movably mated with shaft 750. In one aspect, channel body 50 aincludes a surface feature that mates with a surface feature of shaft750. In the illustrated embodiment, channel body 50 a includes a matingfeature 752 having a curved or c-shaped outer surface corresponding to amating feature 754 of shaft 750. In use, channel body 50 a can slidealong shaft 750 by slide mating feature 752 within mating feature 754.One skilled in the art will appreciate that a variety of movable matingfeatures could be substituted for mating features 752, 754.

While guide tube 26 of FIGS. 7D through 7F is described as mating withbodies that define working or main channels, in another aspect, a toolor instrument could be substituted for one or more of the channels. Forexample, tool 40 and/or an optical device can be substituted for thechannel bodies and directly mated with shaft 750.

In yet another aspect, shaft 750 can include a lumen or lumens definingan additional channel for delivering instruments. A first instrument orchannel body can be mated with shaft 750 while another channel extendsthrough shaft 750. Alternatively, or additionally, the shaft 750 canhave a lumen for delivery or withdrawal of a liquid or gas and/or alumen for housing a control mechanism (e.g., pull wire).

In another embodiment, channel bodies 50 a, 50 b, 50 c, and/or 50 d canarticulate independently of shaft 750 at the distal end of guide tube26. For example, the channel bodies can be detached from shaft 750 andindependently moved via, for example, control wires and/or pre-shapedmaterials. In addition, or alternatively, the guide tube can includevarious structures for causing the channels, instruments within thechannels, and/or the instruments themselves to angle away from oneanother (e.g., diverge).

Further described herein are methods and device for providing tooldivergence and/or convergence for the various embodiments of system 20described herein. In one aspect, the working and/or main channels havean angled configuration relative to the longitudinal axis of the guidetube such that surgical tools diverge or converge as they exit thedistal end of the end cap. The diverging passageways can space thedistal ends of the surgical instruments from one another within a bodycavity. The increased spacing between the surgical tools increases thevolume of the area in which the surgical tools can work (or working withone another), referred to herein as the working volume.

FIG. 8 illustrates one embodiment of guide tube 26 with main channel 42having a diverging configuration. The main channel changes directiontoward the distal end of the guide tube and directs instruments awayfrom the central longitudinal axis of the guide tube. In one aspect, aramped opening 92 a can direct an optical device away from guide tube26. The optical device can then be bent back toward the working area toprovide a “birds eye” view. In one aspect, the optical device can bearticulated (driven via user forces) to bend back toward the workingarea. In another aspect, the optical device can have a pre-bend thatcause the optical device to bend toward the working area after exitingmain channel 42.

In addition, or alternatively, the working channels 44 a, 44 b candiverge from one another or the longitudinal axis of the guide tube. Inone aspect, the working channels change direction at the distal end ofthe guide tube and direct surgical instruments away from one another asthey pass through openings 92 b, 92 c. The angle of openings 92 a, 92 b,92 c can facilitate triangulation of the tools and optical device.

In another embodiment, diverging channels within the guide tube can beprovided by twisting at least two channels around one another. FIGS. 9Aand 9B are partially transparent views of guide tube 26 with workingchannels 44 a, 44 b wrapping around one another to provide a spiralconfiguration. In one aspect, both working channels 44 a, 44 b have aspiral or helical shape proximate to the distal end of the guide tube.In another aspect, only one channel within the guide tube or more thantwo channels have a spiral or helical shape. Regardless, tools passingthrough wrapped channels 44 a, 44 b are angled away from one another asthey leave the guide tube. In one aspect, working channels 44 a, 44 bhave at least about a 90 degree turn, and in another aspect, at leastabout a 180 degree turn.

In another aspect, guide tube channels can exit at a location proximalto the distal-most end of the guide tube. For example, the openings 92b, 92 c through which the tools pass can be positioned proximally withrespect to the distal surface of the guide tube. FIGS. 10A and 10Billustrate openings 92 b and 92 c positioned proximally to the distalend of the guide tube. The working channels bodies 44 a, 44 b extend toopenings 92 b, 92 c in the sidewall of the guide tube 26.

The amount of convergence/divergence of the distal ends of the surgicalinstruments can be varied depending on the intended use. In one aspect,at least one of the passageways has an angle of at least about 7 degreeswith respect to the centerline of the end cap. In another aspect, atleast one of the passageways directs surgical tools at an angle of atleast about 15 degrees.

FIGS. 8 through 10B illustrate example of passive divergence. In anotherembodiment, guide tube 26 provides active or controllable divergence.The amount of divergence between passageways of guide tube 26 can becontrolled via a diverging mechanism. For example, as illustrated inFIG. 11, a sliding ramp or collar 89 can translate relative to the mainand/or working channels to adjust the angle between the passageways ofthe guide tube. The working and main passageways of the guide tube canbe defined by detached (not connected) lumens that are each connected tocollar 89. As collar 89 moves longitudinally it can increase or decreasethe convergence of the passageways.

While FIG. 11 illustrates diverging the working channels to achievedivergences of tools delivered through the channels, in another aspect,the diverging mechanism can directly diverge tools. For example, thediverging mechanism can contact and/or apply force directly on thetools. In one aspect, with respect to FIG. 11, a tool can be substitutedfor channel 50 a and/or 50 b and mate with collar 89.

FIG. 12 illustrates a controllable wedge 120 positioned between tools 40a, 40 b. Pulling a control wire 122 can move the wedge proximally andincrease the angle at which tools 40 a, 40 b diverge. FIG. 13illustrates another embodiment of adjustable divergence between tools 40a, 40 b. The tools can be mated with control wires 122 a, 122 b suchthat tensioning the pull wires causes the tools to bow out and increasetheir convergence. Tools 40 a, 40 b can, in one aspect, also include abias for bending in one direction. For example, the materials of tools40 a, 40 b can be selected to bias the tools to bend in one directionwhen pulled via control wires 122 a, 122 b. As an alternative, aninflatable balloon (FIG. 14) can be used to increase convergence ordivergence of tools 40 a, 40 b. For example, a balloon 124 can bepositioned between and in contact with tools 40 a, 40 b. When inflated,the balloon 124 can apply pressure directly on tools 40 a, 40 b to causedivergence. In still another embodiment, tools 40 a, 40 b can include apre-bend or shape memory material (FIGS. 15A and 15B) that moves into abent position when unconstrained by the guide tube and/or after exposureof the working channels to a trigger (e.g., body heat).

In another embodiment described herein, guide tube 26 includes channelextensions that allow increased curvature or retro-flexing. Asillustrated in FIGS. 16A through 16D, guide tube 26 can includetelescoping curved body 91 that when extended from the distal end of theguide tube 26, assumes a curvature of at least 45°, in another aspect, acurve of at least at 90°, and in yet another aspect, a curve of at least150°. The curved body (or bodies) provides diverging and/or convergingworking channels and can thus provide one or more than one additionaldegree of freedom to the system.

In another embodiment, an s-curve is provided. For example, body 91 caninclude a first and a second pre-formed curves that bend in oppositedirections. In another aspect, body 91 provides a first curve and acontrollable instrument is extended through body 91 and bent to providea second curved portion.

The curved bodies can have a pre-formed curvature that is constrained bya portion of system 20. In one aspect, the guide tube working channel 44constrains curved body 91. A user can push bodies 91 out of the end ofthe guide tube and allows bodies 91 to bend with respect to the guidetube. In another aspect, a stiffening member can constrain the curvebodies. Withdrawing the stiffening member can allow the guide tubeand/or surgical instrument to bend into a pre-curved configuration.

In one aspect, body 91 can rotate in addition to translating withrespect to guide tube 26. In use, body 91 can be rotated relative toworking channel 44 to direct a surgical instrument in a desireddirection. In one aspect, body 91 is rotated into the desiredorientation prior to insertion of guide tube 26 into a patient. Inanother aspect, rotation of body 91 can be controlled by a user from aproximal location.

In yet another embodiment, shown in FIGS. 17 and 18, precurved body 91can be positioned outside guide tube 26. A band 93 extending from guidetube 26 can constrain the pre-curved body until a user moves body 91relative to the guide tube. When the distal end of the body isunconstrained by the guide tube, the pre-curved body can bend into adesired configuration. When the user completes a procedure, the user canmove body 91 back into its original configuration to straighten thepre-curved body and allow withdrawal of the guide tube. Body 91 canhouse a variety of instruments.

Alternatively, band 93 can be moved relative to body 91 and/or guidetube 26. Moving band 93 in a proximal direction can permit body 91 tobend into a preformed curve. The band can then be moved distally tostraighten body 91. In one aspect, a user can control movement of band93 via a push/pull wire (not illustrated) that extends between aproximal controller and the distal portion of guide tube 26.

In another aspect, an optical device extending from guide tube 26 couldinclude a prebend like that of body 91 discussed above. As illustratedin FIG. 19A through 19C, optical device 28 could include a first andsecond prebend spaced longitudinally from one another. As the opticaldevice extends from the guide tube, the first and second prebend canmove the optical device into an s-curve that provides a “bird's eye”view of the work space.

In another embodiment a steerable or positionable ball/socket structurecan be located at the distal end of guide tube 26 for directing toolsand/or optics exiting the working and/or main channels. The ball caninclude a passage defining a portion of the working and/or main channel.Pivoting the ball within a socket can change the direction of thechannel within the ball relative to the guide tube and can directinstruments extending therethrough. Alternatively, optics can bepositioned within a socket structure to allow pivoting of optics.

FIG. 20 illustrates the use of multiple openings 92 a, 92 a′, 92 a″ froma single channel. The user can select the desired opening to reach adesired location relative to the guide tube (rather than having to movethe guide tube). In one such embodiment, the different openings havedifferent angles such that an opening can be selected to change theangle of the instrument with respect to the guide tube. The multipleopenings can extend longitudinally and/or radially around the outersurface of the guide tube.

The choice amongst several openings (e.g., 92 a, 92 a′, 92 a″) from asingle channel (e.g., working channel 44 a) can be controlled byarticulating an instrument. For example, the user can direct ainstrument through a desired opening. Alternatively, or additionally,the guide tube can include articulating ramps that are controlled by aproximally located controller. The ramp associated with a desiredopening can be engaged to direct the instrument through the desiredopening.

In another aspect, the guide tube can include more channels thanopenings 92. For example, two or more channels can merge into a singlechannel in the distal portion of the guide tube. FIG. 21 illustratesfirst and second lumens 44 b, 44 c each containing a tool or opticaldevice, that merge in a single lumen 44 d at the distal end of the guidetube. As shown, tool 40 b extends from the device while tool 40 cremains in lumen 44 c. If a surgeon desires to switch tools, tool 40 bcan be withdrawn into lumen 44 b, and tool 40 c can be advanced into 44d and on to the surgical site. This configuration allows surgeons toswitch quickly between tools without the need to completely withdraw onetool before switching to a second tool.

The desired configuration of the surgical instruments can be achieved byarticulating the instruments in addition to, or as an alternative to,converging/diverging channels. For example, a user can control theinstruments after the instruments exit the distal end of the guide tube.The instruments can be bent, rotated, and/or moved longitudinally toreach a desired working area. Articulation of the instruments isdiscussed in more detail below.

Further described herein are methods and device for preventing theingress of materials (e.g., biomaterials) into the guide tube. In oneembodiment, at least one passageway in the guide tube can include anobturator, end cover, and/or outer sleeve that can prevent or inhibitthe ingress of biological materials into the at least one passagewayduring insertion of the guide tube into a patient. FIGS. 22 and 23illustrate a breakable membrane 90 configured to seal the end of the endcap during introduction to prevent gas, tissue, and/or fluid fromentering the guide tube. In FIG. 22, the breakable membrane 90 is formedas part of an outer sleeve, while in FIG. 23, individual membranes 90 a,90 b, 90 c cover the distal openings 92 a, 92 b, 92 c of the end cap.

FIGS. 24 and 25 illustrate obturators 94 that can be positioned withinthe channels of the guide tube and/or passageways of the end cap. In oneaspect, the plug, obturators, sleeves, and/or membranes can be formed ofa bioabsorbable or dissolvable material. In use, a physician can pushthe bioabsorbable material out of the end of the guide tube to open theguide tube channels. Alternatively, the bioabsorbable material can befast dissolving and the guide tube channels can open when biofluids(e.g., blood or stomach acid) dissolve the plug, obturator, sleeve,and/or membrane. In still another embodiment, non-bioabsorbablematerials are used and a clinician can withdraw the obturators throughthe proximal openings of the guide tube. In yet another embodiment, auser can pierce the sleeve and/or membrane to deliver an instrumentthrough end cap 80. The use of an obturator, sleeve, and/or membrane canpreserve sterility of guide tube 26 and/or inhibit the ingress of fluidsduring insertion of guide tube 26.

FIGS. 26 through 27 illustrate yet another exemplary embodiment of anobturator. A sleeve or cover 97 can shield at least one of the openingsat the distal end of the guide tube. When the guide tube is positionedat a desired location, cover 97 can be moved to expose openings 92 b, 92c. In one aspect, the cover can be controlled via a control wireextending to a proximal controller. Alternatively, as illustrated inFIGS. 26 and 27, cover 97 can be mated with one of the instruments, suchas, for example, an optical device 28. To expose openings 92 b, 92 c,the optical device can be moved away from the distal end of the guidetube causing cover 97 to lift away from openings 92 b, 92 c (FIG. 27)and/or the optical device can be advanced away from the guide tube. Inone aspect, the sleeve does not cover the distal-most end of the opticaldevice, such that optics can be utilized during positioning of the guidetube. In another aspect, the sleeve, skirt, or shroud is transparent orpartially transparent.

Instead of, or in addition to, closing the distal opening of guide tube26, the pressure within the working and/or main channels can beincreased to inhibit ingress of biomaterial. In one aspect, the workingchannels are fluidly connected with a source of pressurized gas orfluid. For example, a compressor, pump, or pressurized vessel can matewith a proximal opening to the working channels.

In another embodiment, the guide tube can store a tool or tools for useduring a surgical procedure. FIGS. 28A through 35 illustrate variousembodiments of a guide tube configured for the storage of a tool such asneedle 100.

Depending on the shape and size of the channels within the guide tube,delivering a curved needle through the guide tube may be difficult.FIGS. 28A and 28B illustrate a recess 102 in which a needle 100 isstored prior to use. Instead of delivering the needle through the guidetube, the needle is housed in a distal portion of the guide tube. Recess102 can have a curved configuration sized and shaped for storing one ormore needles. The recess can be formed separately from the guide tubeworking and main channels or defined by a portion of one the guide tubechannels. In one aspect, the distal end of at least one of the workingchannels is shaped and sized to house a needle. For example, the workingchannel can have a larger width at its distal end. To deliver theneedle, a tool can be moved through the working channel and can grab theneedle and/or push the needle out of the working channel.

Alternatively, recess 102 is separate from the channels of guide tube26. To deliver the needle a pusher wire 104 can be manipulated to movethe needle out of recess 102.

In another embodiment, illustrated in FIGS. 29A and 29B, a needle can bestored in a transverse position. For example, instead of recess 102having a shape and size (e.g., diameter) corresponding to the width ofneedle 100, the recess can accommodate the length of the needle. In yetanother embodiment, a needle can be clipped to the end of the guidetube. For example, FIG. 30 illustrates a needle 100 clipped to thedistal surface 84 of the end cap 80. In still another embodiment, shownin FIGS. 31A and 31B, a needle or needles can be stored in a sleeve 108that extends distally from the distal surface 84 of the end cap 80. Oneskilled in the art will appreciate that one or more needles can bestored at the distal portion of the guide tube. For example, as shown inFIGS. 32A and 32B, multiple needles can be placed in a needle cartridge110 located within the end cap.

As an alternative, or in addition to a needle or needles, the end capcan contain a variety of other tools. In one aspect, as shown in FIGS.33A and 33B, a bag 114 can be stored in, and or deployed from, the endcap. In another aspect, a snare or loop 116, as shown in FIG. 34, can bedelivered from the end cap for grabbing and pulling tissue. In stillanother aspect, illustrated in FIG. 35, multiple tools, such as, forexample, loops, needles, bags, and/or other tools, can be stored in atool kit 118 that is delivered from end cap 80. In use, a surgeon canselect amongst the tools of the tool kit without having to fullywithdraw a surgical tool from the channels of the guide tube.

In another embodiment, end cap 80 and/or tools can be detachably matedwith guide tube 26. A user can choose amongst several end caps and/ortools (or tool sets) and attach the desired end cap or tool to the endof the guide tube. One skilled in the art will appreciate that a varietyof mechanical and/or frictional mating configurations can provide adetachable end cap or tool.

Referring to FIGS. 1 and 36, proximal to the mid-portion 33 of elongatebody 32, guide tube 26 can include a proximal portion 36 that includesapertures for insertion of surgical tools into the channels of the guidetube and controls 30 for manipulating the articulation portion 56 of theguide tube. In addition, proximal portion 36 can be adapted for matingwith frame 22.

In one aspect, proximal portion 36 includes a housing member 150 thatcontains the main and working channels. Housing member 150 can be formedof a rigid material that provides support for controls 30 and that mateswith frame 22. With respect to FIG. 36, the main and working channelscan enter the housing 150 at separate proximal apertures 152 a, 152 b,152 c. In one aspect, proximal apertures 152 a, 152 b, through which theworking channels pass, are positioned in the housing member 150 at alocation distal to the proximal end of the housing member 150 and distalto aperture 152 c. In addition, working channels can exit housing member150 on opposite lateral sides and/or can exit at an angle with respectto the longitudinal axis of the guide tube. For example, housing member150, including apertures 152 a, 152 b, can direct the working channelbodies 50 a, 50 b (which house tools 40 a, 40 b) at an angle withrespect to one another. The size of the angle between working channelbodies, as defined by housing 150, can be varied depending on theintended use of system 20, user ergonomics, and/or the configuration offrame 22.

FIG. 37 illustrates a cut-away view of housing member 150 showing mainchannel 42 and one of the working channel bodies 50 b. Housing member150 can also contain control mechanism 156 of controls 30. Strands 60 a,60 b, 60 c, 60 d (for controlling the proximal articulation portion ofthe guide tube) can exit the outer tubular bodies (46, 48) of mainchannel 42 inside of housing 150. In one aspect, the strands can exitthrough a seal (not illustrated) to prevent liquids or gasses fromexiting main channel 42 and entering the interior of housing member 150.

After exiting main channel 42, strands extend to control mechanism 156and mate therewith. In one aspect, the strands can pass through atensioner 166 between main channel 42 and control mechanism 156. Forexample, where strands are formed by bowden cables, the outer sheath ofthe bowden cables can extend to, but not beyond tensioner 166, while theinner filament extends to control mechanism 156. Tensioner 166 includesa spring 167 that can keep the filament taught between the tensioner andthe control mechanism, while allowing the bowden cables distal to thetensioner to flex and/or translate longitudinally.

In one aspect, control mechanism 156 includes wheels 160 a and 160 b,where two strands (e.g., 60 a, 60 b) mate with one of wheels 160 a, 160b to control left/right movement of the articulation portion 56 of guidetube 26 and the other two strands (e.g., 60 c, 60 d) mate with other ofwheels 160 a, 160 b to control up/down movement of the articulationsection. Depending on the configuration of controls 30, more or fewerthan four strands can mate with more or fewer wheels. For example, whilethe articulation section is described as providing two degrees offreedom, fewer strands and/or wheels can be used where only a singledegree of freedom is necessary. Regardless of the configuration of thecontrol mechanism, the strands can mate with wheels via welding,adhering, mechanically interlocking, and/or frictionally engaging.

The use of two wheels 160 a, 160 b allows independent articulation ofup/down and side-to-side movement of the articulation portion 56 ofguide member 26. Thus, the control mechanism 156 allows independentcontrol of two degrees of freedom. One skilled in the art willappreciate that depending on the desired use of guide tube 26, controlmechanism 156 could alternatively be configured to control two degreesof freedom with a single movement such that the up/down and side-to-sidedegrees of freedom are not independent.

FIG. 38 illustrates a disassembled view of housing 150 showing thevarious components of guide tube controls 30 that are located on anouter surface of housing member 150. First and second dials 170 a, 170 bcan be drive wheels 160 a, 160 b, respectively. In use, operation offirst dial 170 a drives one degree of freedom, while operation of seconddial 170 b drives a second, independent degree of freedom. However, inanother aspect, controls 30 could be configured to manipulated up/downand side-to-side movement with a single movement of one mechanism.Controls 30 also include one or more switches 172 that controls alocking mechanism to lock guide tube 26 in position once a desiredconfiguration of articulation portion 56 is reached. In one aspect, atleast one of switches 172 are friction locks that when tightened,inhibits movement of dials 170 a, 170 b. While the illustratedembodiment is configured to independently lock each degree of freedom,in another aspect, a single switch could lock both dials at the sametime. One skilled in the art will appreciate the variety of conventionalendoscopic locks and steering mechanisms can be used with system 20.

In another embodiment of the guide tube described herein, the guide tubecontrols can be positioned remotely from housing 150. FIG. 39illustrates a perspective view of housing 150 with the main channelextending distally from housing 150. Controls 30′ are positioned on mainchannel 42 proximate to the controls for the optical device. Instead ofthe control mechanism positioned within housing 150, the strands canextend to a control mechanism 156′ positioned on main channel 42.Controls 30′ can include various slides, switches, levers, or other suchmechanisms to control one, two, or more than two degrees of freedom withrespect to guide tube 26. For example, controls 30′ can include thevarious capabilities of controls 30 discussed above.

In one aspect, the distal portion of main channel 42 is flexible topermit the user to position control 30′ at a desired location. Inaddition, having controls 30′ located at a more distal location and/oradjacent to the controls for the optical device, can facilitate userinteraction with the system.

With respect to FIGS. 1 and 36, the proximal end of housing member 150can further include a mating member for mating the housing member toframe 22. As shown in FIG. 36, the frame can include an elongate matingbar 174 that includes a slot 208 for receiving mating member 178 ofhousing member 150. In one aspect, the mating member can slide withinslot 208 and lock in place at a desired location. While the illustratedmating member allows longitudinal movement of the guide tube, oneskilled in the art will appreciate that a variety of additional degreesof freedom can be achieved between frame 22 and guide tube 26. Forexample, guide tube 26 could be moved transversely with respect to theframe, could be moved up and down with respect to the frame, pivotedwith respect to the frame, and/or rotated with respect to the frame. Inaddition, mating can be achieved via guide tube 26 or a separate matingelement that connect frame 22, housing 150, and/or guide tube 26. Inaddition, as described in more detail below, a portion or all of theframe can be incorporated into guide tube 26.

Once the main and working channels exit housing member 150, the main andworking channels can extend to proximal apertures 38 a, 38 b, 38 c (FIG.36) that define the proximal ends of the main channel and workingchannels. In one aspect, the proximal ends of the main and/or workingchannels can include a seal between the wall of the channels and asurgical instrument extending through the channels. The seal can reduceor inhibit the flow of fluid (e.g., solid, liquid and/or gas) to allowinsufflation and/or aspiration of a body cavity and/or to preventretrograde blood flow.

System 20 can include a variety of seals such as, for example, a wiper,septum, and/or duckbill type seal. With respect to the main channel theseal can be sized and shape for receipt in housing 150. The distal endof the seal can mate with the guide tube (e.g., with inner and/or outertubular bodies 46, 48 that defines the main channel), while the proximalend of the seal can form a seal with the instrument passing through themain channel.

FIG. 40A illustrates one exemplary embodiment of a seal 182 position atthe proximal end of working channels 44 a, 44 b. Seal 182 includes anouter surface 192 sized and shaped to mate with a portion of frame 22and an inner surface adapted to prevent the flow of fluid between asurgical instrument and the seal. The proximal end of seal 182 candefine the opening 38 a, 38 b to working channels 44 a, 44 b, while thedistal end of seal 182 can mate with the tubular body defining a portionof the working channel.

FIG. 40A illustrates a wiper-type seal positioned adjacent to theproximal end of a working channel. Blades 180 can be formed of aresilient material such that as a surgical instrument (not shown) ismoved through seal 182, blades 180 form an interference fit with theouter surface of the surgical instrument. In addition, or as analternative, the inner walls of seal 182 can have a size and shapecorresponding to the outer surface of an optical device or tool to limitfluid flow between the outer surface of the surgical instrument and theinner surface of the seal.

FIG. 40B illustrates seal 182 with grommet 194 for supporting seal 182and permitting mating of seal 182 and working channel 44 a with frame22. Grommet 194 can provide a rigid structure having a surface whichcorresponds to a mating surface on frame 22, such as, for example, a “U”shaped bracket of frame 22. One skilled in the art will appreciate thatgrommet 194 can have a variety of shapes and sizes depending on theconfiguration of frame 22 or that grommet 194 can be defined by aportion of frame 22. In addition, working channel 44 can mate directlyto frame 22 without the use of grommet 194.

In addition to apertures for the receipt of surgical instruments intoworking channels 44 a, 44 b and main channel 42, the proximal end ofguide tube 26 can include at least one aperture for the delivery of agas or liquid and/or the application of suction. In one aspect, a fluidcan be delivered and/or withdrawn through one of the channels, such as,for example, the main channel. Alternatively, the fluid can be deliveredand/or withdrawn through a separate channel. And in yet anotherembodiment, the fluid pathway can be defined by a portion of the guidetube between the inner surface of the guide tube and the outer surfaceof the main and working channels or delivered via an instruments thatpasses therethrough.

In one aspect, insufflation gas or suction can be delivered via housing150. An aperture defined, for example by a luer fitting, can provideingress/egress for an insufflation gas. In one aspect, the luer fittingcan be placed adjacent to the entrance of working channel 44.Insufflation gas can be delivered at a variety of locations to system20. For example, pressurized gas can be delivered via a separate lumen,through the main channel, and/or via a more proximally/distallypositioned aperture.

The distal end of guide tube 26 can include apertures for deliveryand/or withdrawal of a irrigation, aspiration, and/or insufflation. Inaddition, or in the alternative, an aperture can be provided for waterjets for the delivery of a liquid for fluid dissection, raising lesions,separating tissue planes, and/or other liquid based procedures. Wherethe guide tube spans an anatomical wall, such as, for example, theabdominal wall, the location of insufflation, irrigation, and/oraspiration apertures can be chosen to deliver or receive fluid to orfrom multiple body cavities. In addition, while transfer of liquids orgasses is generally described, in an alternative aspect, solids could bedelivered or withdrawn.

In one embodiment, at least one opening 196′ for applying suction ispositioned along the outer sidewall of guide tube 26. In addition, asillustrated in FIG. 40C, openings 196′ are located along the distalportion of the guide tube sidewall, but are spaced from the distal-mostend of guide tube 26. The location of suction openings ′196 can permitwithdrawal of fluids (e.g., blood) without the need to withdraw toolsinto guide tube 26 and/or to move guide tube 26 in the distal direction.

In another embodiment of guide tube 26, the working and/or main channelproximal openings are positioned at a location distal to theproximal-most end of the guide tube. For example, an instrument port canbe positioned distal to guide tube housing 150. In one aspect, theinstrument port can mate with a detachable instrument channel. Inaddition, a variety of other ports for delivery of tools, fluids,electrosurgical energy, or other treatment apparatus can be positionedalong the mid or distal portion of the guide tube.

As mentioned above with respect to guide tube 26, the guide tube andinstruments can bend or flex to allow insertion of at least a portion ofsystem 20 along a non-linear or curved pathway. However, in anotheraspect, a portion of guide tube 26 and/or the instruments can be rigid.With respect to FIG. 41A guide tube 26 and/or tool 40 can comprise arigid shaft with an articulation section at a distal end. The guide tubecan have any of the properties and structures described above, but beformed at least in part of rigid materials. Alternatively, or inaddition, a stiffening material can be added to guide tube 26 toincrease rigidity.

In one aspect, the guide tube includes rigid links that are movablymated to one another. As illustrated in FIG. 41B, a rigid link 26 a canpivot with respect to an adjoining link (26 b, 26 c) to allow the guidetube to bend. In one aspect, the links can be driven. For example, pullwire can drive one link with respect to another link. Alternatively, thelinks can move freely with respect to one another. As the guide tube ismoved through a passageway, the contour of the pathway can cause thelinks to move relative to one another and cause the guide tube to bend.

While FIG. 41A illustrates a linear, rigid guide tube, in anotheraspect, the guide tube curved. For example, as illustrated in FIG. 41C,the guide tube can have a rigid, pre-formed shape with at least onechange in direction along its length.

In another embodiment of system 20, guide tube 26 is configured for usein a laparoscopic procedure. In one aspect, a distal portion of guidetube 26 can dock with a laparoscopic port. FIG. 42A illustrates tools 40a, 40 b extending through guide tubes 26 a, 26 b which are mated withports 780 a, 780 b. One skilled in the art will appreciate that avariety of locking structures, including mechanical interlocks and/orfrictional engagements can mate system 20 with ports 780 a, 780 b. Inone aspect, guide tubes 26 a, 26 b include mating features that matewith corresponding mating features on ports 780 a, 780 b.

Alternatively, instead of system 20 mating with laparoscopic ports, theports are defined by a portion of the system such as, for example, guidetube (or tubes) 26. The ports can be integral with guide tube 26 and/orfixedly mated therewith.

In the illustrated embodiment of FIG. 42A a single tool passes througheach of ports 780 a, 780 b. However, multiple tools, fluid lumens,optical devices, and other instruments be delivered through a singleport. In one aspect, illustrated in FIGS. 42B and 42C, tools 40 a, 40 bextend through a single guide tube 26 and through a single port 780.

FIGS. 43A through 43I, describe other exemplary configurations of theguide tube 26, optical device 28, and tools 40 a, 40 b. FIG. 43A,illustrates a non-articulating guide tube. In one aspect, the guide tubecan be bent or articulated into a desired configuration and instruments(e.g., optical device 28 and/or tools 40 a, 40 b) can be articulated toperform a procedure. The instruments in this configuration do not relyon the working channel for articulation. For example, the instruments 40a, 40 b can be supported by a single working lumen 44. FIG. 43Billustrates a guide tube with a built-in optical device. The opticaldevice body can mate with the guide tube, while the distal end of theoptical device is configured to articulate with respect to the guidetube. FIG. 43C illustrates a conventional endoscope with tools 40 a, 40b passing therethrough. FIG. 43D illustrates an articulating opticaldevice with tools 40 a, 40 b passing therethrough. In one aspect, theguide tube of FIG. 43D does not articulate. Instead, guide tube 26, cansupply supporting structure and pathway to enable a procedure at a sitewithin a body. FIG. 43E illustrates a guide tube similar to guide tube26 with an additional tool extending through the optical device.

In another embodiment of system 20, FIGS. 43F and 43G illustrate asystem with no guide tube. Instead, an optical device and tools aremated with one another. With respect to FIG. 43F, a clip 77 defineslumens or apertures through which tools and the optical device pass. Theclip is positioned proximally from the articulation section of theoptical device and tools to allow independent articulation of theinstruments. FIG. 43G illustrates a clip 77′ that holds an opticaldevice and working channels relative to one another. As the opticaldevice articulates, the working channels move with the optical device.In one aspect, the clip detachably mates the working channels andoptical device. In yet another embodiment, illustrated in FIG. 43H,instead of an articulating guide tube for the passage of an opticaldevice and tools, system 20 can include a steerable member to whichtools and/or optics are attached. In still another embodiment,illustrated in FIG. 43I, additional degrees of freedom are provided tosystem 20 with steerable instrument channels. With regard to any of theguide tube and/or instruments discussed above or below, the guide tubeand/or instruments can include more than one articulation section. Forexample, two independent articulation sections can provide additionaldegrees of freedom to the systems described herein. The additionalarticulation section can provide a “wrist” and/or “elbow” to the guidetube and/or instruments.

Frame

As mentioned above, the systems described herein can include a frame formating with the guide tube and/or instruments (e.g., tools 40 a, 40 b,and/or an optical device 28). The frame not only can support theinstruments, but can allow the user to obtain useful control of thoseinstruments. In particular, the frame can provide a reference point formanipulating the various degrees of freedom relative to one another(and/or relative to a portion of the system and/or relative to apatient) in a manner which allows execution of complicated surgicalprocedures. In addition, or alternatively, the frame can permit a userto apply a force relative to the frame to control and/or move the guidetube and/or instruments.

In one aspect, the frame is connected with the instruments and/or guidetube and is defined by a separate and distinct structure. In anotheraspect, various portions and/or all of the frame is incorporated intothe guide tube and/or instruments.

As mentioned above, and with respect to FIG. 1, system 20 can includeframe 22 that is adapted to mate with surgical instruments and/or guidetube 26. In one aspect, referring now to FIG. 44, frame 22 includes anupper portion 200 having a first body 201 for mating with and supportingthe various elements of system 20 and a lower portion 202 (also referredto as a second body 202) that supports the upper portion. In use, frame22 provides a work space for a surgeon to manipulate surgicalinstruments (e.g., tools 40 a, 40 b and optical device 28). In addition,frame 22 can provide a reference between the surgical instruments and apatient.

FIG. 44 illustrates frame 22 without the surgical instruments attached.Frame 22 includes a guide tube mating surface 204, rails 224 a, 224 bfor control members 24 a, 24 b, and an optical device holder 206. In oneaspect, guide tube mating surface 204 allows frame 22 to detachably matewith guide tube 26 such that the guide tube can be inserted into apatient and then mated with frame 22. In use, guide tube mating surface204 can also allow a user to adjust the position of guide tube 26relative to the frame. In one aspect, the guide tube can be mated withan elongate slot 208 on the frame that allows longitudinal movement ofthe guide tube with respect to the frame. Alternatively, oradditionally, guide tube mating surface can be configured to allowpivotal, up/down, transverse, and/or rotational movement of guide tube26 relative to frame 22.

In another aspect, guide tube 26 could be configured for a quickdisconnect from frame 22. For example, FIG. 45 illustrates a post 209that extends from guide tube 26. The guide tube can be mated to frame 22by sliding post 209 into a slot in frame 22. Post 209 can provideadditional degrees of freedom by allowing the guide tube to moverelative to a point of reference (e.g., the frame, the operating room,and/or a patient). For example, the guide tube post can rotate and/ormove longitudinally in frame 22. When the guide tube is in a desiredlocation, the guide tube can be locked in position with respect to theframe. In one aspect, a lock, such as, for example, locking collar 211can allow a user to quickly attach/detach the guide tube and frame.Alternatively, or additionally, a locking features such as a clamp orpin (Detail B) can frictionally or mechanically engage post 209.

FIG. 46 shows a another example of a quick release defined by amale/female interlock 203 with a switch 205 configured to lock the guidetube and frame. The male or female portion of interlock 203 can bepositioned on the guide tube while the other of the male or femaleportion can be positioned on the frame. Seating the male portion in thefemale portion and closing switch 205 can lock the guide tube and frame.

In another aspect, locking guide tube 26 to frame 22 locks the rails 224to the frame. For example, as shown in FIG. 45, rails 224 can be matedwith or defined by a portion of guide tube 26. The rail and guide tubecan then be attached/detached from frame 22 as a single unit.

Regardless, the ability to adjust the guide tube with respect to theframe allows a user to change the location of the working volume of thetools with respect to the frame. As mentioned above, the space in whichthe distal end of the tools can move adjacent to the distal end of theguide tube is the working volume. Because the tools have a limit to theamount of travel (longitudinal movement and/or articulation) relative tothe guide tube, the working volume is not unlimited. However, by movingthe guide tube (and therefore the tools) relative to the frame, thelocation of the working volume is changed.

In another aspect, moving the first body member 201 (which is attachedto the guide tube) relative to the second body member 202 can change thelocation of the working volume. The first body member can have one, two,three, or more degrees of freedom of movement with respect to the secondbody member which provide one, two, three, or more degrees of freedom inwhich to adjust the location of the working volume. With respect toFIGS. 44 and 45 (and as discussed in more detail elsewhere), frame 22can permit, for example, the first and second body members to pivot,rotate, and/or move forward/back, up/down, and/or side-to-side. Once theworking volume is in the desired location the first body member can thenbe locked with respect to the second body member. Similarly, moving thewhole frame relative to a point of reference (e.g., a patient) canchange the location of the working volume.

In one embodiment, frame 22 can include a holder 206 upon which asurgeon can rest optical device 28. Holder 206 allows the user to steadyoptical device 28 before and/or after placing the optical device in adesired orientation. For example, the optical device can be placed inholder 206 and then articulated. Adjustability of the holder allows theuser to rotate the optical device such that the image viewed by the usermatches the user's orientation (i.e., the image is not upside down)and/or the orientation of the surgical site. The holder provide alocation for the user to place the optical device so that the opticaldevice will hold its orientation during a procedure and allow access tocontrols for articulation.

In one aspect, with respect to FIG. 44, holder 206 comprises a three armstructure such that a surgeon can have a full range of motion whenadjusting the position of an optical device relative to frame 22. In oneaspect, a first and second arm 210, 212 are rigid and a third arm 214 isflexible. Third arm 214 can be adapted to hold its position once bentinto a desired configuration by a user. For example, the force requiredto move third arm 214 can be greater than the force applied by theweight of optical device 28 when placed in holder 206. In anotheraspect, illustrated in FIG. 47, holder 206 can include a telescoping armin addition, or as an alternative, to first, second, or third arm 210,212, 214. The holder of FIG. 47 can allow pivoting and/or rotationalmovement in addition to telescoping. In yet another aspect, a singleflexible arm could be used to allow articulation of holder 206.

Holder 206 can include first and second pivot points 216, 218,respectively. As shown in FIG. 44, holder 206 is mated with frame 22 viaa first pivot point 216. First arm 210 can extend between first andsecond pivot points 216, 218, while second arm 212 extends betweensecond pivot point 218 and third arm 214. Pivot points 216, 218 can alsobe designed to hold their position once place in a desiredconfiguration. Alternatively, or additionally, holder 206 can includelocks that a user can activate to prevent movement of pivot points 216,218.

Holder 206 can mate with a variety of surgical instruments, such as, forexample the illustrated optical device 28. In one aspect, holder 206includes a clip 220 into which optical device 28 can sit. Clip 220 canhave an open sided configuration which relies upon gravity and/orfriction to hold optical device 28 in place. Alternatively, clip 220 caninclude a locking mechanism (not illustrated) to prevent movement ofoptical device 28 relative to clip 220.

As mentioned above, upper portion 200 can further include rails 224 a,224 b that receive controls 24 a, 24 b for tools 40 a, 40 b. Rails 224a, 224 b allow control members 24 a, 24 b to move longitudinally and/orto pivot with respect to other portions of system 20 (e.g., frame)and/or the surrounding environment (e.g., with respect to a patient).Since the rails can be defined by a portion of frame 22, by a portion ofguide tube 26 (e.g., part of housing 150), and/or as a stand alonestructure, the rails will be described in a separate section below.

The lower portion 202 of frame 22 can have a variety of configurationsadapted to support upper portion 200 and to hold frame 22 in placerelative to a patient and/or an operating table. In one aspect, lowerportion 202 has a tripod configuration that rests on an operating roomfloor. To facilitate movement of frame 22, the frame can include wheelsor sliders. For example, FIG. 48 illustrates system 20 mounted on arollable lower portion 202. Frame 22 allows rolling or sliding of theguide tube and tool 40. In addition, the frame of FIG. 48 can allow auser to adjust the angle of rail 224, guide tube 26, and/or tool 40.

The connection between the upper and lower portions can be configured toallow upper portion 200 to move relative to the lower portion 202. Asshown in FIG. 44 upper portion 200 can be pivoted and lock in positionrelative to upper portion 200.

In another aspect, lower portion 202 can mate with an operating tablesuch that frame 22 moves with the operation table as the table andpatient are moved. FIG. 49 illustrates system 20 mated to an operatingtable rail. In one aspect, frame 22 is adjustably mated with a frame ofan operating room table.

In yet another aspect, system 20 can be mounted on a movable chair. FIG.50 illustrates system 20 mounted on a chair 246 that can be moved viarolling. In still another aspect, as shown in FIG. 51, system 20 can beharnessed to a physician.

As mentioned above, in one aspect, the rail is movably mated with frame22, for example, via pivoting joints. In another aspect, additionaldegrees of freedom can be provided to rails 224 a and/or 224 b withrespect to frame 22, an operating room, and/or a patient. For example,FIG. 47 (discussed above) illustrates a holder 206 that can provide one,two, three, or more than three degrees of freedom to an opticalinstrument. In one aspect, the rails can be mounted on an adjustableframe similar to holder 206 to permit adjustment of the rails withrespect to the guide tube 26 and/or to improve user ergonomics.

In other embodiment, illustrated in FIG. 52, the rails can be mounted toan optical device. A user can hold the optical device 28 (e.g.,endoscope) in one hand and drive the control member 24 a with the otherhand. As described below, the control member 24 a and rails 224 a canfacilitate control of multiple degrees of freedom with a single hand.Mounting rail 224 a to the endoscope can permit manipulation of opticalcontrols 215 and surgical instrument handle 24 a via a single user. Therail 224 a can be mounted at various angles, such as, for example,parallel to the optical device control housing.

In one embodiment, the catheter body of instrument 40 a has sufficientrigidity that moving handle 24 a along rail 224 a cause the body (anddistal end) of instrument 40 a to move relative to the optical device 28(and/or relative to a frame, patient, point of reference, etc.). Forexample, a user can torque handle 24 a and cause the body of instrument40 a to rotate. Similarly, moving the handle longitudinally along therail can cause the body of instrument 40 a to move longitudinally withina working channel in optical device 28.

In one aspect, optical device 28 acts as the frame. In another aspect aseparate structure could provide support to optical device 28 and act asthe frame. In one such aspect, tissue or a natural body orifice acts asa frame to support optical device 28.

With respect to FIG. 52, a strap 213 mates rail 224 a with opticaldevice 28. However a variety of other detachable or fixed matingfeatures can be used to attach rail 224 a to optical device 28.

Rails

In one aspect, control members 24 a, 24 b of tools 40 a, 40 b can matewith rails 224 a, 224 b. As mentioned above, rails 224 a, 224 b can beformed by a portion of frame 22. However, in another embodiment, therails can be defined by or mate with another portion of system 22 and/orbe used without a frame. In addition, while the discussion belowgenerally refers to two rails, the systems described herein can includea single rail or more than two rails.

Generally, the rails and control members allow a user to manipulate(i.e., move and/or freeze) multiple degrees of freedom of the tools. Forexample, the tools 40 a, 40 b can be moved longitudinally with respectto and/or rotated with respect to the rails (or another portion ofsystem 20) to control longitudinal and/or rotational movement of thedistal ends of the tools (i.e., the end effectors). However, not only dothe rails permit movement and provide a frame of reference for a user,but they can also facilitate control of multiple degrees of freedom.Thus, in addition to providing multiple degrees of freedom, the systemsdescribed herein can enable a user to make use of the multiple degreesof freedom. In one aspect, the system 20 allows a user to controlmultiple degrees of freedom with a single hand. In another aspect,system 20 permits simultaneous control of multiple degrees of freedom(e.g., movement of tool 40 relative to a patient while manipulatingcontrol member 24).

As described above, in one aspect, tools 40 a, 40 b include proximalcontrol members 24 a, 24 b, elongate bodies referred to herein ascatheters 25 a, 25 b, and distal end effectors 502. The various elementsof tools 40 a, 40 b are described in more detail below, however for thepurpose of discussing rails 224 a, 224 b, it should be understood thatthe rails mate with the proximal control members 24 a, 24 b andfacilitate movement of the proximal control members 24 a, 24 b. Movingthe proximal control members relative to the rails (or another portionof system 20) is one way to control the movement of catheters 25 a, 25 band the end effectors 502. In one aspect described below, rotatingand/or translating the proximal control members causes the catheters andend effectors to rotate and/or translate relative to the rails, frame,and/or guide tube. Thus, the rails can provide one, two, or more thantwo degrees of freedom to each tool.

In another aspect described below, the proximal control members can befixedly mated with the rails and the rails can move relative to theframe, guide tube, and/or patient to provide one, two, or more than twodegrees of freedom to each tool. In yet another aspect described below,the tools can be movable mated with the rails and the rails can moverelative to the frame, guide tube, and/or patient. For example, movementof the rails can provide one or more degrees of freedom to the tools(e.g., rotation and/or longitudinal movement) and movement of the toolsrelative to the rails can provide one or more additional degrees offreedom (e.g., rotation and/or longitudinal movement of the tools withrespect to the rails).

In one embodiment, rails 224 a, 224 b extend proximally from frame 22.In use, a surgeon can stand or sit with control members 24 a, 24 b onopposites sides of his or her body. To improve ergonomics, rails 224 a,224 b can be adjustable with respect to frame 22. FIG. 53 illustratesframe 22 with rails 224 a, 224 b attached to frame 22 at pivot points226 a, 226 b. In another aspect, rails 224 a, 224 b, could be attachedto frame 22 such that the position of the rails can be adjusted andlocked with respect to frame 22. For example, the rails can be adjustedlongitudinally, moved up/down, rotated, and/or moved transversely withrespect to frame 22 to accommodate different users. In addition, morethan two rails can be provided. In yet another aspect, two rails couldbe stacked on one another.

In one aspect, the rails 224 a, 224 b constrain movement of the controlmembers 24 a, 24 b within a control member volume. The maximum travel ofthe control members (longitudinal movement and rotation) defines thecontrol member volume. Adjusting the rails with respect to the frame canchange the location of the control member volume. In another aspect,adjusting the frame (e.g., movement of first body member 201 relative tosecond body member 202) can change the location of the control membervolume.

In one embodiment, the rails can extend from the system in a non-linearconfiguration. For example, FIG. 54 illustrates curved guide rails thatarc around a user. The curved rails can improve user ergonomics and/orallow for longer rails. For example, the curved rails can provideincreased control member travel while keeping the control members withinreach of the user. Depending upon the user and/or the intended use ofsystem 20, the curve of the rails can be adjustable. A user can bend therails into a desired configuration.

FIG. 55 illustrates one embodiment of the connection between rail 224 aand control member 24 a. Control member 24 can include guide members234, 235 (referred to as “clamps” in another embodiment below) extendingfrom the surface of the control member and mating with rail 224 a.Generally the guide members have an aperture or recess corresponding tothe outer surface of the rail. The connection between the control memberand rail allows relative translation and/or rotation between the controlmember and rail. While two guide members 234, 235 per control member areillustrated, one skilled in the art will appreciate that the guidemembers can have a variety of alternative configurations, such as, forexample a control member with a single guide member.

While rails 224 a, 224 b are illustrated as having a generally circularcross-section shape, rail 224 a and/or rail 224 b could have a varietyof alternative configurations. In addition, the cross-sectional shape ofthe rails can be chosen to control the movement of the control membersrelative to the rails. The rails can have a non-circular cross-sectionalshape, such as, for example, a rectangular, oval, elliptical,triangular, and/or irregular shape that prevents relative rotation ofthe control member. In one aspect, the shape of the rails can preventrotation of the control member relative to the rails. However, not allnon-cylindrical rails prevent rotation of the control member withrespect to the rails.

In another aspect, the rails can have a groove or protrusion whichcorresponds to a groove or protrusion on the control members. FIG. 56illustrate an exemplary configurations of rail 224 a that allowtranslation of control members 24 a, but inhibits rotation of thecontrol member with respect to the rail. The groove/protrusion providesa “keyed” pathway that allows one degree of freedom while inhibitinganother. In one aspect, the keyed pathway allows relative translationalmovement, but can prevent relative rotational movement of control member24 a with respect to rail 224 a. If rotation of the tools is desired,the control members 24 a, 24 b could rotate independently of rails 224a, 224 b (described in more detail below) and/or the rails could rotatetogether with the control members (also described below). In anotheraspect, the keyed pathway can limit the range of motion or travel of thecontrol member with respect to the rail.

In one embodiment, the rails can include stops to limit the travel ofthe control members relative to the rails. As illustrated in FIG. 55,stops 230, 232 limit longitudinal movement of guide members 234, 235. Aportion of rail 224 a having a larger size than the inner diameter ofguide member 235 can limit distal movement. Conversely, proximal stop230 can be formed separately from rails 224 a and mated therewith. Forexample, stop 230 can be defined by an adjustable locking nut that auser can lock at a desired location. In another aspect, both stops 230,232 are adjustable. In use, a clinician can position stops 230, 232 toadjust the amount of travel of the control member.

In another aspect, at least one of the stops could be defined by a quickdisconnect feature that allows rapid mating of control members 24 a, 24b with rails 224 a, 224 b. If a user wishes to remove control member 24a from rail 224 a, the quick disconnect stop can be manipulated to allowthe control member to slide off of the rail. FIG. 57 illustrates oneexemplary quick disconnect 230 defined by a spring loaded ball. FIGS.58A and 58B illustrate a rail end stop that can move between a lowprofile configuration that (FIG. 58A) that permits passage of guide 234and an off-center configuration (FIG. 58B) that prevents passage ofguide 234. In the low profile configuration, the outer surface of stop230 does not extend beyond the outer surface of the rail. In theoff-center configuration, stop 230 pivots away from the rail andprevents passage of control member 24.

In one aspect, only the proximal stop 230 is a “quick disconnect” stop,however, both proximal and distal stops 230, 232 can have a quickdisconnect configuration. In another embodiment, the connection betweencontrol member 24 a and rail 224 can be a quick disconnect. For example,guide member 234 can detachably mate with rail 224 a.

In one aspect, the movable connection between the control member and therail and/or between the rail and the frame requires user input in orderto move tool 40 a, 40 b. The amount of force required to move controlmember 24 can be chosen such that gravity alone does not cause thecontrol member to move when a user removes their hand. In one aspect,the guide members 234, 235 can be configured to allow translation and/orrotation while providing some frictional resistance to movement. Thus,when a user removes a hand from the control member, the frictionalresistance between the control member and rail will hold the controlmember in place relative to the rail, the guide tube, the frame, apatient, and/or a reference point. One skilled in the art willappreciate that the materials and/or inner dimensions of the guidemembers, rails, and/or frame can be chosen according to the desiredfrictional resistance.

In another aspect, system 20 includes a damper to increase the forcerequired to move the tools. For example, the damper can prevent movementof a tool where the force applied by the user is below a predeterminedthreshold and/or can limit the maximum velocity of the tool. Inaddition, or alternatively, the damper can smooth the resultant toolmovement from a user's input forces. If the user's inputs are jerky orinconsistent, the damper can improve the consistency and/orpredictability of tool movement.

A variety of dampers can be used with system 20. FIG. 59A illustrates anadjustable constricting ring 601 that allows a user to control thefrictional resistance to movement of tool 40. In another aspect, ahydraulic damper could be incorporated into system 20. For example,where two parts of the system move with respect to one another (e.g.,the control member with respect to the rail and/or the rail with respectto the frame), a hydraulic damper can damp relative movement.

In another aspect, the damper can damp one degree of freedom to increasethe force required to move the tool in the one degree of freedom, butnot damp another degree of freedom. In one example, the damper canincrease the force required to move the tool longitudinally, but not theforce required to rotate the tool and/or not the force required tomanipulate the handle of the control member. Damping one degree offreedom without damping another can reduce the chance of unwanted ornon-intuitive tool movements where two degrees of movement arecontrolled by similar user inputs.

In addition, or in the alternative, system 20 can include a brake orlock for preventing movement of control members 24 a, 24 b relative tothe rails, guide tube, frame, patient, and/or point of reference. In oneaspect, when engaged, the lock can increase resistance to movementbetween the rail and control member and thereby inhibit movement of thetool. While a variety of locks can be used, in one aspect, system 20includes a lock that can independently lock different degrees offreedom, such as, for example lockable roller bearings. In use, movementof the roller bearings in one direction is inhibited to lock one degreeof freedom of the control member. In another embodiment, the lock caninhibit multiple degrees of freedom and include, for example,frictionally or magnetically driven brakes. A magnetic lock can includean electromagnet positioned on the rail and/or control member and aferrous substance positioned on or defining a portion of the controlmembers 24 a, 24 b and/or rails 224 a, 224 b.

FIG. 59B illustrates another embodiment of a lock for inhibitingmovement between the control member and rail. In one aspect, the acollar 760 extends at least partly around rail 224. When tightened,collar 760 can inhibit rotation and/or translation of control member 24with respect to rail 224. Collar 760 can be used in addition to guidemembers 234, 235 or can be substituted for one or both the guidemembers. Thus, in one aspect, locking collar 760 can mate control member24 and rail 224.

In one aspect, collar 760 can be controlled via an actuator on controlmember 24 to permit on-the-fly locking. For example, pull wires canextend between the control member and collar 760 to permit locking ofcontrol member 24 without a user removing his or her hand from thecontrol member.

In another embodiment, the control member 24 can be locked usingmagnetic rheological fluid. A portion of control member, or a structuremated with the control member, can move through magnetic rheologicalfluid as the control member travels along the rail. To lock the controlmember, a magnetic field can be applied to the fluid, locking thecontrol member in place with respect to the rail. FIG. 59C illustratescontrol member 24 and rail 224, with rail 224 extending into a chamber785 containing magnetic rheological fluid. As rail 224 moves intochamber 785, the fluid flows through a constricted area 787 of chamber785. In order to inhibit further movement of rail 224 and control member24, a magnetic field is applied with magnet 789, causing the magneticrheological fluid to stiffen.

Chamber 785 can include a counter force defined by springs 791. Afterremoving the magnetic field rail 224 can be moved backwards. Springs 791can force the magnetic rheological fluid back through constricted area787 as rail 224 withdraws from chamber 785. The rail and springs cantherefore apply opposing forces to move the magnetic fluid back andforth as the rail moves back and forth.

In one aspect, rail 224 and springs 791 can include a fluid seal 793 toprevent leaking of the fluid. In addition, the seals 793 can prevent thepassage of air into passage 785 and inhibit separation of rail 224 fromthe magnetic rheological fluid. Thus, locking or stiffening the magneticrheological fluid can additionally inhibit backward movement of controlmember 24 via suction.

In other aspect, rail 224 and/or control member 24 can be locked and/ordamped directly with magnets. For example, rail 224 can be ferrous. Amagnet can be moved into position and/or activated to inhibit movementof the rail. In one aspect, a portion of system 20 adjacent to rail 224can be magnetized to inhibit movement of the rail.

As mentioned above, tools 40 a, 40 b can include proximal controlmembers 24 a, 24 b and distal end effectors. In some cases, a user maywish to determine the distance traveled by the distal end of the tools,based on the location of the proximal control members. In one aspect,rails 224 a, 224 b can include visual and/or tactile feedback to assistwith determining the location of and/or distance traveled by the distalend of the tools 40 a, 40 b. FIG. 60 illustrates one embodiment of amarking system 236 that can be positioned adjacent to rail 224 to assistthe user with determining the location of and/or distance traveled bythe tools. Indicia 236 on the rail, frame, tool, and/or surroundingenvironment can permit a user to determine tool location and/or measuretool movement. The indicia are positioned to allow measurement of thedistance traveled by control member 24 relative to frame 22 and/or rail224. In one aspect, translational movement of control member 24 relativeto rail 224 and/or frame 22 can be measured with indicia. In anotheraspect, indicia allow measurement of rotational movement of controlmember 24 relative to rail 224 and/or frame 22

While system 20 is generally described with respect to one tool perrail, the use of more than one tool per rail is contemplated. Forexample, tools 40 a, 40 b can be positioned adjacent to each other on asingle rail. In addition, or alternatively, system 20 can include morethan two tools on two or more rails. FIG. 61 illustrates one example oftwo control member 24 a, 24 b positioned on a single rail 224. Inanother aspect, system 20 can include multiple rails with multipletools.

The control members 24 a, 24 b illustrated in FIGS. 1 and 44 rotateabout an axis defined by the rails, which is offset from the entrance toguide member 26 and offset from the location of catheters 25 a, 25 b. Asa result, when the control members 24 a, 24 b rotate about rails 224 a,224 b, the rotational movement of the control members can cause not onlyrotational movement of the catheters, but can also cause longitudinalmovement (push/pull movement) of the catheters. In other words, where auser inputs only rotational movement to the control members, theresulting movement of catheters can include both rotational andlongitudinal movement. Because one degree of movement of the controlmembers (rotation) influences two degrees of movement of the catheters(rotation and translation), a user may find that control of tools 40 a,40 b via movement of control members 24 a, 24 b is not intuitive.

Described herein are various embodiments of system 20 adapted todisconnect (or minimized the influence of) the rotational movement ofthe tools from (on) the longitudinal movement of the tools. Generally,these embodiments are referred to as “on-axis” systems.

In one embodiment, system 20 can include catheter holders 242 a, 242 b.The catheter holders can align at least a portion of the catheters withthe rotational axis of the control members. With respect to FIGS. 1 and44, the catheter holders 242 a, 242 b can align the catheters 25 a, 25 bwith an axis L-L defined by rails 224 a, 224 b (the axis of rail 224 ais indicated by a dashed line L-L in FIG. 44). In use, catheters 25 a,25 b can extend from the control members 24 a, 24 b; through an aperturein the catheter holders 242 a, 242 b, which is coaxial with rails 224 a,224 b; and into guide tube 26.

The catheter holders 242 a, 242 b can allow rotation and/or longitudinalmovement of the catheters with respect to the catheter holders, whilekeeping a portion of the catheter aligned with the rotational axis ofthe control members 24 a, 24 b. In one embodiment, shown in FIG. 44, thecatheter holders 242 a, 242 b can be defined by “U” shaped holdershaving an open upper surface. In use, the catheters can be quicklyattached/detached from frame 22 by sliding the catheters 25 a, 25 binto/out of holders 242 a, 242 b. The catheter holders inhibit radialmovement (i.e., movement in a radial direction away from the rotationalaxis of the control members), but allow axial and/or rotational movementof the catheters.

While the illustrated catheter holders 242 a, 242 b extend from aportion of frame 22, the catheter holder can be mated or defined by adifferent part of system 20. For example, the catheter holders can bedefined by or mate with guide tube 26, with rails 224 a, 224 b, and/orwith another frame.

In one aspect, catheter holder 224 a, 224 b additionally oralternatively mate with the working channels 44 a, 44 b. For example,the catheter holders can mate with a portion (e.g., the proximal end) ofthe working channel bodies. In one aspect, the catheter holders candetachably or fixedly mate with the working channel bodies. In anotherembodiment the catheter holders can be integral with or defined by theworking channel bodies. Regardless, the catheters, in one aspect, canmate with the catheter holders by passing through the working channelswhile the working channels are mated with the catheter holders. Thecatheter holders can thereby inhibit radial (but not longitudinal and/orrotational) movement of the catheters with respect to the frame and/orworking channels at the location where the catheters mate with (e.g.,extend through) the catheter holders.

In another embodiment, control member 24 can rotate independently of therail. The axis of rotation of the control member can provide independentrotation and longitudinal movement of tool 40. In one aspect, the axisof rotation corresponds to a portion of the catheter. In one example,the tools can rotate around an axis that extends through a pointproximate to the interface between the control member and the catheter.In another aspect, the control member can rotate about an axis definedby, or in close proximity, to an axis defined by a portion of thecatheter.

FIGS. 62A through 62C illustrate control member 24 a configured torotate about an axis co-linear with a portion of catheter 25. Withrespect to FIG. 62A, the control member can rotate about an axis C-Cthat is coaxial with a portion of catheter 25. In one aspect, axis C-Cextends through catheter 25 adjacent to control member 24. In anotheraspect, axis C-C extends through the location at which catheter 25 mateswith control member 24.

As illustrated, control member 24 can rotate independently of rail 224while rail 224 remains fixed in position. In one aspect, control member24 includes first and second body member. The first body member canmovably mate with the rail and movably mate with the second body member.The movable connection between the first body member and the rail canprovide one degree of freedom, for example, longitudinal movement. Themovable connection between the first body member and an the second bodymember can provide another degree of freedom to the control member (withrespect to the frame, rail, and/or guide tube), such as, for example,rotation. In the illustrated embodiment of FIGS. 62A through 62C, afirst body member 233 is defined by guide member and a second bodymember 228 is defined by a portion of control member 24 that rotatablymates with the first body member.

The first body member 233 can mate with rails in a variety of ways,including, for example, via a lumen which receives rail 224 a. In oneaspect, first body member 233 can translate relative to rail 224 a, butcannot rotate relative to rail 224 a. For example, as mentioned above,rail 224 a can have a non-cylindrical configuration that mates with anon-cylindrical lumen of the guide member. The first body member caninclude a proximal arm and a distal arm that movably mate with secondbody member 228. FIGS. 62B and 62C illustrate exemplary mating featuresthat allow one degree of freedom, rotation, of the second body member228 of control member 24 relative to the first body member 233 and rail224. In particular, the proximal arm of the guide member can define ashaft around which control member 24 rotates. Alternatively, theproximal arm can receive a portion of the control member configured forrotation within the proximal arm (FIG. 62C). The distal arm can have aconfiguration similar to the proximal arm. Alternatively, as illustratedin FIG. 65A, the distal arm can define a support cradle that allowsrotation of the control member relative to rail 224 a.

Providing a control member that rotates around its own axis permits tool40 to freely rotate. In particular, catheter 25 will not wrap aroundrail 224 as the control member 24 is rotated.

In another “on-axis” embodiment, the rails can rotate around thecatheter and/or around an axis defined by, or in close proximity, to anaxis defined by a portion of the catheter. FIG. 63A illustratesrotatable rail 224 defined by a cradle 225 and including first andsecond elongate members. Control member 24 can move longitudinallyrelative to rail 224, but cannot pivot or rotate about the rail.However, cradle 225 is movable mated to system 20 such that that cradleand control member can rotate together. In one aspect, the rotationalaxis of cradle 225 is aligned with catheter 25 such that rail 224 andcontrol member 24 rotate around an axis co-linear with a rotational axisof the catheter. In particular, the catheter 25 can pass through theaxis of rotation of cradle 225. For example, the cradle can include anaperture at the axis of rotation.

In another “on-axis” embodiment, at least a portion of the catheter ispositioned within the rail. In addition, the rail can rotate about thecatheter and/or the rail and catheter can rotate together. The axis ofrotation can be defined by the rail and/or by the catheter within therail. For example, rail 224 can rotate and/or move longitudinally withrespect to the frame. In one such embodiment, illustrated in FIGS. 64Aand 64B, instrument 40 fixed mates with rail 224, such that the controlmember 24 and rail 224 move together to provide one or more degrees offreedom to tool 40. The rail movably mates with the frame to allowrotation and/or longitudinal movement. When a user applies a rotationand/or translational pressure on control member 24, rail 224 can moverelative to rail mount 239, frame 22, and/or guide tube 26.

As shown in FIG. 64B, the catheter 25 of tool 40 can extend through aportion of rail 224. Having catheter 25 extend through rail 224 (andthrough rail mount 239) can permit co-axial rotation of the controlmember, rail, and catheter. In addition, tool 40 can freely rotatewithout the catheter entangling frame 22 or wrapping around rail 224.

FIG. 64C illustrates another embodiment of rail 224 rotatably mated withframe 22. The rotatable connection between the rail and frame permitstool 40 to rotate relative the frame, guide tube (not illustrated),patient (not illustrated), and/or another point of reference. In orderto provide longitudinal movement, rail 224 can move with respect to theframe and/or the control member can slide along rail. In one aspect,rail 224 is movably mates with the control member to allow the controlmember to translate with respect to the frame, guide tube, point ofreference, etc. For example, a portion of the rail can be receivedwithin the control member and movably mated therewith. Regardless,unlike FIGS. 64A and 64B, the catheter need not be positioned within therail.

In one aspect, with respect to FIGS. 64A through 64C, movement of rail224 is limited by collar(s) 227 (FIG. 64A) positioned on either end ofthe rail. Contact of collar 227 with rail mount 239 can act as a stop tolimit longitudinal movement of tool 40.

In yet another embodiment, a portion of catheter 25 can define the rail(not illustrated). For example, the catheter can include a generallyrigid section that movably mates with a frame, such as, for example,rail mount 239. Control member 24 and catheter 25 can be moved togetherrelative to the frame, guide tube, surrounding environment, and/or apatient to control movement of the instrument.

While the distal ends of the rails are described as mated with system20, the proximal ends of the rails can alternatively mate with thesystem. FIG. 65 illustrates frame body 201 connected to rails 224 a, 224b at the proximal end of the rails. The catheter bodies 25 a, 25 b oftools 40 a, 40 b can extend distally to guide tube 26 (not illustrated).Proximal mating of rails 224 a, 224 b with the frame of system 20permits rotation of control members 24 a, 24 b without catheters 25 a,25 b of tools 40 a, 40 b wrapping around or tangling with frame 22. Inaddition, control members 24 a, 24 b can be rotate 360 degrees or more.

In one aspect, the proximal ends (or a region proximate to the proximateends) of the rails can mate with a crossbar 237 that extends from frame22. For example, rails 224 a, 224 b can extend through an aperture orlumen in crossbar 237. Alternatively, each of the rails 224 a, 224 b canmate with separate with portions of the system or separate frames.Regardless, the connection between rails 224 a, 224 b and system 20 caninclude the various features of the control member/rail connectiondescribed above, including, for example, a locking feature toselectively inhibit movement between rails 224 a, 224 b and frame 22.

The control members 24 a, 24 b can be fixedly mated with rails 224 a,224 b. Moving the rails longitudinally and/or rotationally results in acorresponding movement of tools 40 a, 40 b. In one embodiment, insteadof a user directly manipulating the control members 24 a, 24 b, a usercan interface with the rails or with a handle attached to the rails. Forexample, in FIG. 65, rails 224 a, 224 b can include proximal knobs 238a, 238 b that allow a user to control at least one degree of freedom,and in another aspect, each knob allows a user to control two degrees offreedom of tools 40 a, 40 b. For example, the user can controllongitudinal and/or rotational movement of tools 40 a, 40 b with knobs238 a, 238 b. In one aspect, a user can rotate the tool 360 degrees ormore without releasing the knobs. One skilled in the art will appreciatethat the knobs are exemplary of the various handles or controllers thatcan be used to manipulate tools 40 a, 40 b, via rails 224 a, 224 b.

In another embodiment, knobs 238 a, 238 b can be configured to allow auser to control additional degrees of freedom. Knob 238 a and/or knob238 b can include the features of handle 304 (described below) toactuate at least one degree of freedom of a distal end effector. In oneexample, knobs 238 a, 238 b can include a trigger for controllingactuation of a distal end effector.

In the illustrated embodiment of FIG. 65, control members 24 a, 24 brotate around the axes of rails 224 a, 224 b. In one aspect, rails 224a, 224 b could be co-axial with a portion of catheters 25 a, 25 b topermit rotation of tools 40 a, 40 b and/or knobs 238 a, 238 b around anaxis corresponding the catheters.

In still another embodiment of “on axis” rails used with the systemsdescribed herein, a rail can extend through a portion of control member24 and/or catheter 25. FIGS. 66A and 66B illustrate control member 24and catheter 25 with rail 224 extending through at least a portion ofcatheter 25. Tool 40 can rotate about rail 224 and/or movelongitudinally on the rail. With rail 224 extending through a portion ofcatheter 25, the axis of rotation of control member 24 (or tool 40) canbe co-linear or nearly co-linear with at least a portion of catheter 25.As illustrated in FIG. 66B, rail 224 can be slightly offset from thecentral axis of catheter 25 and still allow independent control ofrotation and translation of tool 40 via control member 24.

Rail 224, of FIGS. 66A and 66B, in one aspect, is formed of a rigid orsemi-rigid material. In another aspect, the rails can have varyingrigidity such as a bendable or flexible segment that permits rail 224and catheter 25 to follow a non-linear pathway and/or to articulate.

In one aspect, rail 224 mates with system 20 or the surroundingenvironment at a location proximal to the proximal end of the controlmember. Having rail 224 extend through at least a portion of thecatheter can allow the rail to act as a guide wire. The rail 224 canfirst be directed to a target location and then used to position guidetube 26 and/or tool 40 a. For example, the rail can be used in a fashionsimilar to a guide wire. In another aspect, rail 224 can be used todeliver electrosurgical energy. For example, the proximal end of rail224 can be connected to an electrosurgical generator and can deliverenergy to the distal end of tool 40, such as, for example to an endeffector positioned at the end of tool 40.

In another embodiment of system 20, at least a portion of the controlmember 24 can be positioned within rail 224. FIG. 67 illustrates asleeve 267 in which a portion of control member 24 sits. The controlmembers can have at least one degree of freedom with respect to sleeves.As shown in FIG. 67 the sleeves 267 can each include an elongate slotsized and shaped for the passage of the control member handle 304 topermit the control members to move longitudinally with respect to therails. To rotate tool 40, the control members 24 and sleeves 267 canrotatably mate with the frame (not illustrated). Rotating the controlmembers 24 and sleeve together can rotate tools 40 and provide a seconddegree of freedom to tool 40.

In one aspect, rail 224 can house at least a portion of catheter 25 andsleeve 267 of FIG. 67 provides “on-axis” rotation of tool 40. In afurther aspect, the axis of rotation of rail 224, as defined by sleeve267, can be co-linear with a portion of the catheter. In yet a morespecific aspect, the catheter can pass through the axis of rotation ofsleeve 267. As a result, rotation of tool 40 is independent oftranslational movement of tool 40.

As mentioned above, the rails described herein can be mated with orincorporated into other portions of system 20 besides frame 22. FIGS.68A and 68B illustrate rails incorporated into guide tube housing 150.In one aspect, rails 224 a, 224 b are defined by sleeves 267 which arerotatably mated with housing 150.

In another aspect, illustrated in FIGS. 69A and 69B, instead of thecontrol members moving within sleeve 267, the control members include asleeve 267′ that receives a portion of rails 224 (as defined by guidetube housing 150). Sleeve 267′ is configured to moveably mate with therail and allow rotational and/or longitudinal movement of tools 40 a, 40b. In addition, sleeve 267′ can provide “on-axis” rotation of tool 40.

While a frame is not illustrated in FIGS. 68A through 69A, a frame couldbe used to support guide member 26 and/or sleeves 267. However, aseparate frame device is not necessary to support the system of FIGS.68A through 69B. For example, as shown in FIG. 69B, the guide tubehousing 150 could mate with an operating table, patient, floor, ceiling,and/or other operating room structure.

In another embodiment, instead of moving the control members 24 a, 24 brelative to the rails (or moving the rails relative to the frame) toachieve longitudinal movement, the sleeves could have a telescopingconfiguration. FIG. 70 illustrates telescoping rails 224 having multiplesegments 1224 a, 1224 b movably mated with one another. Longitudinalmovement can be achieved by moving one of the segments into anothersegment. For example, a first segment 1224 a can have a size and shapecorresponding to an open channel within a second segment 1224 b. Thus,pulling the control members toward the user causes telescopic expansionof rail 224. Similarly, the control members can be moved toward housing150 by collapsing sections of the telescoping rail. While twotelescoping segments are illustrated, three or more than three segmentscould be used.

In another aspect, the telescoping rail of FIG. 70 provides tool 40 withtwo degrees of freedom relative to the frame, guide tube, and/or apatient. For example, the segments 1224 a, 1224 b can rotate relative toone another to permit rotational movement of tool 40. Alternatively, thetelescoping rail could provide only a single degree of freedom (movinglongitudinally) and rotation of tool 40 could be provided by rotatablymating the telescoping rail with the control member and/or with theframe.

In one aspect, catheter 25 extend through the multiple segments of thetelescoping rail to provide on-axis rotation of tool 40. In anotheraspect, control member 24 and telescoping rail 224 can rotate about anaxis co-linear with the catheter axis.

The rails described can provide functionality in addition, or asalternative, to enabling tool articulation. In one embodiment, one orboth of the rails 224 a, 224 b can control articulation of guide tube26. As described above, guide tube 26 can include an articulationportion 56 that can move up/down and/or left/right. In one embodiment,the rails 224 a, 224 b can control at one degree of freedom of the guidetube 26, and in another embodiment, the rails can control two, or morethan two degrees of freedom of guide tube 26.

In one aspect, described above, the guide tube is controlled via strands60 that extend from the distal articulation section of the guide tube toa proximal controller. As shown in FIGS. 71A and 7B, the strands canextend to rail 224 or to a location proximate to rail 224. In oneaspect, rail 224 can movably mate with guide tube 26 to permit rotationof the rail with respect to the guide tube. Strands 60 can extend torail 224 and mate therewith, such that rotating rail 224 pulls (and/orpushes) on strands 60. Thus, moving rail up and down with respect to theguide tube can control at least one degree of freedom of guide tube 26,and in particular, can control up and down movement of the articulationsection of the guide tube. Similarly, rail 224 can be configured topivot in a left/right configuration. When rail 224 is pivoted, strands60 can be pulled (and/or pushed) to control at least one degree offreedom of the guide tube, and in particular, left/right movement of thearticulation segment of the guide tube.

Thus, movement of rails 224 a, 224 b relative to guide tube 26 can drivemovement of the guide tube. Alternatively, the guide tube housing caninclude a first and second body member. Movement of the first bodymember relative to the second body member can articulate the guide tube.In one aspect, the first body member can be fixedly mated with a rail orrails such that movement of rails moves the first body member withrespect to the second body member and articulates the guide tube.

In one embodiment, the guide tube includes a joint 241, movement ofwhich can drive a articulation of the guide tube. Joint 241 can matewith strands 60 such that pivoting joint 241 pulls (and/or pushes) onstrands 60. Joint 241 can also be configured to allow locking of rail224. For example, joint 241 can be comprised of an upper segment 243 anda lower segment 244. Upper segment 243, when unlocked, can pivot tocontrol movement of strands 60, and conversely, when the upper and lowersegments are locked to one another pivoting of the rail is inhibited.The upper and lower segments 243, 244 can include mating surfaces withcorresponding surface features such that when the mating surfaces of theupper and lower segments are in contact with one another, the matingsurfaces can engage one another and prevent movement of joint 241. Oneskilled in the art will appreciate that a variety of mating features,such as corresponding protrusions and grooves, can inhibit movement ofthe upper and lower segments 243, 244 when the mating surfaces are incontact. To unlock joint 241, a controller, such as foot pedal 245 (FIG.72), can be activated to lift the upper segment 243 away from lowersegment 244 and allow relative movement between the upper and lowersegments.

The upper and lower segments of joint 241 can lock in a variety ofalternative ways. For example, instead of mating protrusions/grooves,joint 241 can include a ball and detent system. FIG. 73 illustrates aspring loaded ball positioned on upper segment 243, that when activated,will engage detents on the lower segment 244. In one aspect, the balland detent arrangement does not prevent articulation, but inhibitsunwanted movement of the guide tube. After a user positions the guidetube in the desired configuration, the ball/detent lock can preventunwanted movement of the rails. In another aspect, the force (i.e.,spring) on the ball can be removed or reduced to allow movement of joint241. One skilled in the art will appreciate that a variety of otherlocking features can be used to prevent unwanted movement of the guidetube articulation segment. In one exemplary embodiment a friction lockor mechanical lock prevent articulation of guide tube 26.

FIGS. 74 through 79 illustrate yet another embodiment of system 20 andrails 224 a, 224 b comprising a movable and detachable connectionbetween rails 224 a, 224 b and frame 22. In one aspect, illustrated inFIG. 75, connection 602 comprises a first mating plate 604 and a secondmating plate 606. When mated, the first and second mating plate includea passage 608 for catheter 25. In one aspect, passage 608 is co-linearor nearly co-linear with the axis of rotation of control member 24 topermit “on-axis” rotation of tool 40. FIGS. 76A and 76B illustrate frontviews two embodiments of first mating plate 604, 604′. First matingplate 604, 604′ can include an offset lip 610 having a curved perimeterwhich can interlock with a corresponding hook 612 or hooks 612 on secondmating plate 606. FIG. 77 illustrates first and second mating plates604, 606 mated with one another. In user, hooks 612 can slide around theperimeter of offset lip 610 to permit rotation of second mating plate606 with respect to first mating plate 604.

In one aspect, hooks 612 are disposed toward the upper surface of secondmating plate 606 such that that second mating plate hangs on the firstmating plate. The mating features (lip 610 and hooks 612) of thedetachable connection 602 are sized and shaped to allow slidingtherebetween. When a user torques tool 40, hooks 612 can slide over thetop surface of lip 612 and permit rotation.

In one aspect, rotation beyond a predetermined angle will result indetachment of the first and second mating plates. As hooks 612 slidearound lip 610, the hooks can fall of the side of lip 610. Thedetachable connection 602 can further include a lock to prevent unwanteddetachment of the first and second plates. In one aspect, second matingplate 606 includes a pivotable latch 680 (FIG. 77) that can interlockwith a corresponding feature on first mating plate 604. When secondmating plate 606 is rotated beyond a predetermined distance, a portionof latch 680 can contact the surface of the first mating plate 604.Contact of latch 680 with first mating plate 604 can prevent furtherrotation of the second mating plate with respect to the first matingplate. To detach first and second mating plates 604, 606, latch 680 canbe can be pivoted into a non-locking configuration. One skilled in theart will appreciate that other locking mechanisms, including variousmechanical interlocks and frictional engagements can be substituted forthe latch locking mechanism.

In another embodiment, a snap-ring can mate the first and second matingplates. FIGS. 78 and 79 illustrates detachable connection 602′ includinga snap ring 682 that mates with second mating plate 606′ and correspondsto lip 610 of first mating plate 604, 604′. When the first and secondplates are mated, snap ring 682 surrounds lip 610 to prevent accidentaldetachment of the first and second mating plates.

As mentioned above, the first and second mating plates can includepassageway 608 for receiving a portion of tool 40 and for allowingmovement of at least a portion of the tool through the passageway. Inone aspect, passageway 608 includes on open upper surface to allow auser to place tool 40 in passageway 608. For example, passageway 608 canhave a “U” shape as illustrated in FIG. 75. In another embodimentpassageway 608′ can be enclosed by the walls of the first and/or secondmating plates 604, 606. For example, as illustrated in FIG. 78, acircular opening in the first and second plates allows passage of atleast a portion of tool 40.

While several of the rail configuration described with respect to system20 constrain movement of the tools along a linear pathway or pathways,frames and/or rails with different constraints are also contemplated. Inone aspect, a frame and/or rail can constrain a control member tomovement within a plane. For example, the control member can be matedwith a surface that allows side-to-side movement in addition toforward-back movement. In another aspect, the control member can matewith a frame with a frame that permits movement in three dimension withrespect to the frame, guide tube, patient, and/or point of reference.For example, the control member can be moved side-to-side, forward-back,and up-down. Alternatively, or additionally, the control member can berotated. In one aspect, the up-down and/or side-to-side movement of thecontrol member controls articulation and/or actuation of the catheter.For example, moving the control member up-down and/or side-to-side cancontrol up-down and/or side-to-side movement of a distal portion of thecatheter.

Instruments

Further disclosed herein are various tools for use with the systemsdescribed herein. In addition to one or more degrees of freedom providedby moving the tools relative the guide tube, frame, and/or rails, thetools themselves can enable additional degrees of freedom. For example,the tools can include a distal articulation section that can moveup/down, left/right, and/or end effectors that actuate. As used herein,the term “articulation” refers to a degree of freedom provided by movingthe body of the tool and does not require a particular tool structure.In other words, the articulation section is not necessarily comprised oflinked segments that move relative to one another to provide toolmovement. Instead, for example, a flexible shaft can be bent to providearticulation. Described below are exemplary embodiments of the controlsmembers, catheters, and/or end effectors that can comprise tools 40 a,40 b.

As discussed above, control members 24 a, 24 b articulate catheters 25a, 25 b, and/or end effectors. FIGS. 80A through 80E illustrate one suchembodiment of a control member 24 including an actuator handle 304 thatallows a user to control the orientation of a distal tip of tool 40 aswill be explained below. The handle further includes a trigger 306 thatallows a user to actuate an end effector.

In one embodiment, control member 24, is coupled to the rail with one ormore U-shaped clamps 300 and 302. As shown in FIG. 80B, Each of theU-shaped clamps includes a pair of spaced-apart arms 308 that areconnected to a pair of side rails 310 a, 310 b that extend for thelength of the control member and form a frame to which additionalcomponents of the control member can be secured.

While control member 24 is described as including side rails 310 a, 310b as supporting structure for the various elements of the controlmember, other control member configurations are contemplated. Forexample, the outer walls or shell of the control member can provide ananchor or frame to which various portion of the control membermechanisms can be mated. However, with respect to FIGS. 80A through 80Eand the accompanying description below, rails 310 a, 310 b areillustrated and described.

In one aspect, actuator handle 304 is rotatably coupled to the siderails 310 a, 310 b such that the handle is able to move forward and aftrelative to the control member 24. In addition, the handle 304 canrotate about a longitudinal axis of a shaft 314. Movement of the handleback and forth causes the distal tip of the tool 40 to move in one planewhile rotation of the actuator handle 304 about the longitudinal axis ofthe shaft 314 causes movement of the distal tip of the tool 40 inanother plane.

In one aspect, the amount of force required to move the control memberrelative to rail 224 can be chosen such that movement of handle 304relative to the body of control member 24 does not accidentally causearticulation or actuation of the tool 40. In one aspect, the forcerequired to translate or move control member 24 in a proximal and/ordistal direction is greater than or equal to the force required to pushhandle 304 forward and/or pull handle 304 back (i.e., move handle 304 ina proximal/distal direction). The force required to move control member24 can be adjusted by increasing the amount of friction between thecontact surfaces of the control member and rail. In another aspect adamper can increase the force required to move control member 24. In yetanother aspect, the amount of force required to move control member 24is adjustable.

Handle 304 can be secured to the pair of side rails 310 a, 310 b with atrunnion 316. Trunnion 316 includes a pair of outwardly extending posts318 a, 318 b that fit in corresponding holes formed in the side rails310 a, 310 b. A locking mechanism such as a snap ring or other fastenercan secure the posts 318 a, 318 b into the side rails. Alternatively, oradditionally, the post can be secured by sandwiching between the siderails.

The handle 304 can be rotatably secured to the trunnion 316 with a shaft320. Shaft 320 can mate with a collar 324 that provides a stop for abowden cable as will be described in further detail below. Although thestop is illustrated on collar 324, in another aspect, the stop can belocated inside handle 304. The trunnion 316 further includes a stopplate 326 that provides an anchor for the ends of the bowden cablehousings. The stop plate 326 pivots back and forth with the posts 318 a,318 b as the handle 304 is moved back and forth in the control. Thetrunnion 316 further includes a slot in the center of the trunnion inwhich a cable guide plate or disk 328 is located.

In the illustrated embodiment of FIGS. 80C, 80D, and 80E, the cableguide plate 328 is generally circular and includes a groove 330 thereinin which an actuating cable 332 is fitted. The cable guide plate 328includes a notch 334 that receives a corresponding cable stop 336 thatis secured to the cable 332 (while a single notch/stop is illustrated,additional notches/stops are contemplated). The cable is wrapped aroundthe cable guide plate 328 and includes a pair of legs (or wires) thatare coupled directly and indirectly to the distal end of the tool.Movement of the cable guide plate causes corresponding tension orrelaxing of the legs of the cable 336. The cable guide plate 328 isfitted into a slot within the trunnion such that it lies behind the stopplate 326. The shaft 320 fits through a corresponding hole in the cableguide plate 328 and a snap ring or other fastening mechanism secures thecomponents together. Rotation of the handle 304 causes a correspondingrotation of the shaft 314 which in turn is coupled to the cable guideplate 328 to tension or release the legs of the actuating cable 332.

Cable 332 is illustrated as wrapped around disk 328 more than 360degrees. In another aspect, cable 336 can be wrapped around the diskmore than about 180 degrees, and in another aspect more than about 270degrees. In yet another aspect, cable 332 mates to disk 328 withoutwrapping around a portion of the disc.

FIGS. 80D and 80E illustrate further detail of the trunnion 316 withinthe control member 24. The cable guide plate 328 is fitted within theslot of the trunnion 316 and rotates back and forth within the slot byrotation of the actuator handle 304. To limit the amount of forward andaft movement of the handle 304 in the control member, a ring 340 fittedover the posts of the trunnion 316 can have a notch 342 therein. A pin344 secured in the side rail (not shown) limits how far the handle cantravel by engaging the end of the notch 342. While the FIGS. illustratea ring/pin configuration, one skilled in the art will appreciate that avariety of alternative mechanisms can be used to limit motion of thecable guide plate. In addition, the illustrated configuration could bereversed such that the notch could be located on the side rail and thepin could be located on the trunnion.

Also shown in FIGS. 80D and 80E is a cable 346 that is actuated by thetrigger mechanism 306 on the handle. Depressing the trigger 306 causes atensioning of the cable 346 to actuate the distal end of the tool. Inthe illustrated embodiment, the cable 346 is a bowden-type cable havingan outer sheath 348 with one end secured to a cable stop 350 positionedon the collar 324 that is fitted over the shaft 314. The other end ofthe bowden cable housing extends through a cross bar 354 and joins astop at the distal end of the catheter. The crossbar 354 also includesstops for the bowden cable housings that are driven by rotation of thehandle as described above.

As shown in FIGS. 80D and 80E, the trunnion also includes a shaft thatextends in a direction perpendicular to the posts that are coupled tothe side rails. The shaft includes a pair of cable receivers 356, 358having a slot or other receptacle therein that secures an end of anarticulation cable. One of the cable receivers 358 is below the pivotpoint of the trunnion 316, and the other is above the pivot point. Upontilting the trunnion 316 in the control member, the cable receivers 356,358 selectively tension or release control cables that move the distaltip of tool 40 in a plane.

Further detail of one embodiment of a trigger mechanism 306 is shown inFIG. 81. In this embodiment, the trigger 306 is rotatably receivedwithin the handle 304 such that squeezing the trigger 306 causes it torotate about a pivot point. The trigger 306 includes an arm 360 to whichan end of the actuation cable 346 is secured. As the arm 360 is moved bypressing the trigger, tension on the control cable 346 is increased toactuate the tool at the end of the medical device. A roller or pulley362 changes the direction of the control cable 346 from within thehandle to a direction that extends along the shaft 320.

FIGS. 82A and 82B illustrate another embodiment of trigger mechanism 370that includes a button 366 for activating the distal end of tool 40. Abowden cable 368 can extend into handle 304 to trigger mechanism 370.The second end of the outer sheath 372 of the bowden cable extends inclearance through crossbar 354 and through the body of surgical toolwhere it terminates proximate to end effector. The outer sheath 372 ofthe bowden cable 368 can mate with a stop 374 in the trigger mechanismwhile the inner filament 376 extends into trigger mechanism 370. Whenbutton 366 is depressed, trigger mechanism 370 tensions inner filament376. In one aspect, trigger mechanism 370 include a ratchet-type lockthat prevents the release of inner filament 376 once tensioned. A button378 can be depressed to release inner filament 376 and allow the distalend of tool 40 to return to its original configuration.

While the various control cables or control wires in the control member24 are illustrated as bowden-type cables, other cables, filaments, andwires can be substituted. In one exemplary embodiment, unsheathed pullwires are substituted for at least some of the bowden cables. As usedherein, “control cables” can refer to any wire, filament, or cable thattransmits actuating and/or articulating forces along the body to tool40.

In one embodiment, the control cables extending between the controlmember and the distal end of the tool include a detachable connectionthat permits detachment of catheter 25 from control member 24. FIGS. 83Aand 83B illustrate one embodiment of a coupling mechanism that can beused to selectively couple one or more of the control cables of controlmember 24 to one or more control cables within catheter 25 of tool 40.The coupler 380 forms an end-wall that is positioned within the controlmember housing between the support rails 310 a, 310 b. Coupler 380 has anumber of spring loaded pins 382 a, 382 b, 382 c, etc., positionedtherethrough. The proximal end of pins 382 a, 382 b, 382 c, etc., isconnected to a control cable that is manipulated by handle 304 or thetrigger mechanisms as described above. In addition, each pin includes adistal cable receiving notch or slot 384 therein that receives a cableterminal or stop of a corresponding control cable 386 a, 386 b, 386 c,etc. extending through catheter 25. Securing the cable terminals in theslots 384 of each pin mates cables 386 a, 386 b, 386 c, etc. withcorresponding control cables in control member 24.

In the embodiment shown, each of the pins 382 a, 382 b, 382 c, etc.includes a spring 388 a, 388 b, 388 c that biases the pin in the lockedposition. Compressing the spring allows removal or insertion of thecable terminals into slots 384. In addition, or alternatively, springs388 can tension the control cables within the body of the controlmember. When the control handle is released by a user, the springs canbias the control handle in a home position.

In one aspect, the various cables within control member 24 can beadjustably tensioned. For example, in one embodiment spring loaded pins382 can have a threaded connection with coupler 380. Rotating pins 382can move pins laterally to control the tension on control wires mated topins 382. For example, rotating the pins 382 can compress or relaxsprings 388 to adjust tension on the control wires.

Coupler 380 can comprise a variety of different mechanical connectionsfor detachably mating the control cables of control member 24 andcatheter 25. In one aspect, instead of notch 384 and cable terminal,coupler 380 can include a threaded connection, snap fit, and/or othermechanical interlock.

FIG. 83B illustrates an exemplary quick disconnect 422 for disconnectingthe control cables of catheter 25 from the control member 24. The quickdisconnect can directly mate the control cables of control member 24with the control cables of catheter 25. In one aspect, the directconnection includes a wire terminal and corresponding terminal receiversdefined by slot 384. The terminal receivers can be mounted in and housedby a support base 630 (illustrated in an exploded view). After matingthe terminals with the terminal receivers, a ring 632 on catheter canmate with the support base. The support base 630 and ring 632 canenclose the mated control cables and prevent unwanted control cabledisconnection by limiting the freedom of movement of the matedterminals/terminal receivers.

In another embodiment of control mechanism 24, system 20 can include aorientation adjuster. In use, the orientation adjuster can allow a userto rotate the elongate catheter body and distal end of a tool relativeto control mechanism 24. FIG. 84 illustrates a cross-section of thedistal end of control mechanism 24 with adjuster 394. Adjuster 394, inone aspect, can include an inner member 390 having a passageway 392. Thepassageway 392 can receive the elongate catheter body of tool 40 (notillustrated). In one embodiment, the catheter body of tool 40 includesan outer sheath that fixedly mates to the inner surface of passageway392. One skilled in the art will appreciate that a variety of matingmechanisms, such as, for example an adhesive, mechanical interlock,and/or frictional engagement can be used. In addition, the inner member390 can mate with the inner surface of adjuster 394. For example, asillustrated in FIG. 84, adjuster 394 includes an aperture 396 for a setscrew for mating adjuster and inner member 390. In another aspect,adjuster and 394 and inner member 390 can be fixedly mate via, forexample, an adhesive. In addition, the adjuster and the inner member canalternatively be formed as a single body.

To change the rotational orientation of tool 40, adjuster 394 can berotated within control member 24. In one aspect, a locking collar 395can be tensioned to control the amount of friction between the controlmember and orientation adjuster 394. For example, the locking collar 395can be set to inhibit, but not prevent rotation of the adjuster, or setto prevent rotation until adjustment is desired. Since adjuster 394 ismated to inner member 390, and inner member 390 is mated to the body oftool 40, rotating adjuster 394 causes catheter 25 to rotate relative tocontrol member 24.

In one aspect, tool 40 can include indicia to facilitate alignment ofthe catheter with the control member. For example, markings on thecatheter proximate to the control member can correspond to theorientation of the distal end effector at the distal end of catheter 25.In use, a clinician can use the indicia to align the catheter andcontrol member.

In another aspect, the amount of rotation of the catheter with respectto the control member is limited with a stop. For example, a surfacefeature on the orientation adjuster (not illustrated) can contact acorresponding surface feature (not illustrated) on the control memberbody to inhibit rotation more than a predetermined distance. Becausecontrol wires extend from catheter 25 into control member 24, rotationgreater than about 360 degrees can significantly increase the forcesrequired to articulate catheter 25 and/or can cause tangling of thecontrol wires. In one aspect, stops can prevent rotation more than about360 degrees, and in another aspect, can prevent rotation more than about180 degrees in either direction (clockwise/counterclockwise).

As mention above, passageway 392 can receive catheter 25. In one aspect,passageway 392 can include a distal region sized and shaped to receivethe outer surface of the catheter 25. In addition, passageway 392 caninclude a proximal region adapted to prevent proximal movement of thecatheter. In one aspect, the proximal region of passageway 392 can havea cross-section that is smaller, in at least one dimension, than theouter surface of the catheter, but large enough to allow passage ofcontrol cables therethrough. The proximal region can thereby preventproximal movement of the catheter beyond passageway 392 and into (ordeeper into) control member 24.

In one aspect, the proximal region acts as a counter force when thecontrol cables are tensioned or pulled. The proximal region can hold thecatheter body in place to allow the control cables to move relative tothe elongate catheter body.

In the exemplary control members described above, the control cablesextending from trunnion 316, plate 318, and/or trigger 306 extend to andmate with a firewall or coupler 380. Different control cables thenextend through catheter 25 and mate with a distal articulation sectionand/or distal end effector. In another embodiment, control cables canextend directly from the control mechanism (e.g., trunnion 316, disk328, trigger 307) of control member 24 to the distal articulationsection and/or distal end effector. FIG. 85 illustrates control cables386 a, 386 b, 386 c extending into catheter 25 without the user of afirewall, coupler, or detachable connection.

A variety of alternative control members, which allow a distal end oftool 40 to be actuated in the up/down, right/left, forward/backward, androtational directions, can be used with system 20. Such alternativecontrol mechanisms are disclosed, for example, in U.S. patentapplication Ser. No. 11/165,593, entitled “Medical Device ControlSystem” and U.S. patent application Ser. No. 11/474,114, entitled“Medical Device Control System,” both of which are hereby incorporatedby reference in their entirety.

In addition, described below are a variety of alternative embodiments ofcontrol member 24 and alternative control mechanisms that can besubstituted for the trunnion 316, disk 328, and trigger 307 describedabove. FIG. 86 illustrates a swash plate 400 that allows a user tocontrol multiple degree of freedom with a single handle. One suchexemplary control member is described in U.S. Pat. No. 3,605,725. Theswash plate can work with a “joystick” type handle to control twodegrees of freedom.

FIG. 87 provides a transparent view of another embodiment of a swashplate control member. In one aspect, the shaft 320 of swash platecontrol member 24 can have a bend, such as, for example, a 90 degreebend that allows use of handle 304 instead of a joystick. In addition,handle 304 can provides an additional degree of freedom via trigger 307.For example, handle 304 can include a button or trigger for controllingactuation of the distal end effector.

In yet another embodiment of a swash plate control member, illustratedin FIG. 88, rotation of tool 40 can be provided by rotating controlmember 24. For example, a handle can be rotatably fixed to a shaft thatcontrols a swash plate. While the user interfaces with the handle, withthe palm of his or her hand, the user can simultaneously interface acontrol knob with a digit (e.g., thumb or pointer) to achieve rotationof tool 40. FIG. 88 illustrates control member 24 mated with handle 304via a rotatable connection such that handle 304 can rotate with respectto the control member. To rotate tool 40, a user can turn control member24 and catheter 25 independently of handle 304. In addition, a user canmove the control member relative to a rail, frame, guide tube, or otherreference point by pushing/pulling on handle 304 to provide longitudinalmotion.

While handle 304 can rotate with respect to control member 24 andcatheter 25, the rotatable connection between handle 304 and shaft 320can allow a user to drive other degrees of freedom. When a user moveshandle 304 up/down and/or side-to-side, user input forces can driveswash plate 400. Movement of swash plate 400 can drive various degreesof freedom of tool 40 including, for example, articulation of catheter25. In addition, longitudinal user input forces, such as pushing/pullingalong an axis parallel to tool 40, can also be delivered through shaft320 to drive tool 40.

In yet another aspect, control member 24 can permit independent rotationof the end effector with respect to catheter 25 and/or with respect tocontrol member 24. FIGS. 89A and 89B illustrate one embodiment of acontrol mechanism that permits independent rotation of the end effector.Control cable 368 extends from control member 24, through catheter 25,to a distal end effector (not shown). Rotating control cable 368independently of catheter 25 and control member 24 can drive rotation ofthe end effector with respect to catheter 25.

In one embodiment the use of a first and second swash plate 400 a, 400 bcan permit independent rotation of control cable 368. Second swash plate400 b can be mated with control cable 368 such that rotation of handle304 cause control cable 368 to rotate. Conversely, control cable 368 canrotate independently of first swash plate 400 a. In one aspect, controlcable 368 extends through an aperture within first swash plate 400 athat allows relative rotation between control cable 368 and first swashplate 400 a.

Control cable 368 can be a torquable, flexible filament, coil, cable, orwire that transmits torque to the distal end effector. In one aspect,control cable 368 can additionally drive actuation of the end effectoras described herein. For example, where distal end effector actuation isdesired, handle 304 can include a trigger or similar mechanism toactuate the distal end effector.

Rotational movement of second swash plate 400 b is disconnected fromfirst swash plate 400 a. In one aspect, cross bars 640 a, 640 b extendfrom second swash plate 400 b and movably mate with first swash plate400 a via slots 642 a, 642 b. While two cross bars are illustrated,three, four, or more than four cross bars could extend between the firstand second swash plates. As second swash plate 400 b rotates, cross bars640 a, 640 b move along slots 642 a, 642 b to allow independent rotationof second swash plate 400 b with respect to first swash plate 400 a.

Additional degrees of freedom can be provided to drive catheterarticulation via side-to-side and/or up-down movement of handle 304. Ashandle 304 is moved up/down or side-to-side, cross bars 640 a, 640 b cantransmit forces from second swash plate 400 b to first swash plate 400a. For example, cross bars 640 a, 640 b can transmit forces parallel toa longitudinal axis of the cross bars and/forces parallel to therotational axis of control cable 368. Thus, tilting second swash plate400 b on an axis orthogonal to the rotational axis R-R can drive thefirst swash plate and transmit user inputs to control cables 368 a, 368b, 368 c, and/or 368 d mated with first swash plate 400 a.

FIG. 89B illustrates swash plate 400 b rotated about an axis R′-R′ thatis orthogonal to the rotational axis of control cable 368 to drivearticulation of catheter 25. Note that cross bars 640 a, 640 b transmitpush/pull forces from the second swash plate to the first swash plateand cause first swash plate 400 a to pivot in a fashion corresponding tosecond swash plate 400 b. In one aspect, swash plates 400 a, 400 bremain parallel to one another as they pivot.

FIG. 90 illustrates a pistol grip 402 handle that include controls knobs404 on the grip of the handle. Knobs 404 (similar to the control knobsdescribed above with respect to the guide tube controls 30) cansubstitute for a trigger control, or be used in addition to triggercontrol.

FIG. 91 illustrates a control knob 406 positioned on the proximal end ofthe control member 24. In one aspect, moving control knob 406 canarticulate an end effector. The proximal location of control knob 406facilitates control of tool 40 as the tool rotates with respect to theframe, rails, guide tube, and/or point of reference. As control member24 rotates 180 degrees or more, a user may have to switch hands oradjust their grip on a standard handle. Having knob 406 positioned onthe proximal end of control member 24 can facilitate control of tool 40while control member 24 rotates around rail 224.

In one aspect, control knob 406 is rotatably mated with control member46. A user can rotate control member 24 to control rotational movementof tool 40. In another aspect, knob cannot rotate with respect tocontrol member 24 and rotation of knob 406 can drive tool rotation.

FIG. 92 illustrates a control member including a flexible body 409 matedwith pull wires. Moving the flexible body 409 results in actuation ofthe distal end of the tool. The control member of FIG. 92 can alsoinclude a sliding sleeve 410 for and/or a handle 304 for controllingadditional degrees of freedom.

FIG. 93 illustrates a control member including a knob or ball 412 forcontrolling a degree of freedom. In one aspect, rotating the knob 412can drive rotation of catheter 25 with respect to the body of controlmember 24. For example, the catheter 25 can be configured to rotateindependently of control member 24. Rotating knob 412 can drive gears orpulleys 413 (or other such mechanism) and rotate catheter 25. In anotheraspect, a lever or moment arm of tool 40 (not illustrated) can rotatethe catheter. For example, a lever could be mated with a torque coilextending through catheter 25. Movement of the lever could drive thetorque coil and rotate the catheter and/or distal end effector 502.

FIG. 94 illustrates another embodiment of the control member 24including handle 304 for controlling additional degrees of freedom.While similar to the control members discussed above having a controlhandle that drives two degrees of freedom, the control member of FIG. 94includes a second rotational actuator (e.g., knob) driving an additionaldegree of freedom of catheter 25. In one aspect, rotational actuators433 a, 433 b can rotate with respect to one another and with respect tothe housing of control member 24. Rotational actuator 433 b can drive adisk within control member 24 via a shaft extending from handle 304 intocontrol member 24. Similarly, rotational actuator 433 a can drive asecond rotating disk.

The additional degree of freedom controlled by the second rotationalactuator 433 a can include a second articulation section 622 in additionto first articulation section 623 driven by the first rotationalactuator 433 b. In one aspect, articulation section 622 can be placedproximally to the first articulation section 623, giving a “wrist” andan “elbow” to catheter 25. This additional degree of freedom can allowinstruments to converge and/or diverge with another tool. Additionally,the control mechanism can include an trigger 744 to actuate end effector502. The control handle of FIG. 94 can provide four degrees of freedom,which when used with the rails described above, can provide aninstrument with six degrees of freedom. In one aspect, all six degreesof freedom can be controlled with a single hand.

FIG. 95 illustrates a control member 24 having a “ball-type” handle 414.Moving the ball mechanically drives the distal end of the tool. In oneaspect, ball handle 414 includes control wires wrapped around thecurvature of the handle. Pivoting handle 414 with respect to shaft pulls(or pushes) on control wires and drives movement of tool 40.

In yet another embodiment, FIG. 96 illustrates a control member having atrigger grip configuration that provides “on-axis” rotation.Articulation of the tool can be controlled by, for example, by movementabout a pivot or swash plate. Rotation of tool 40 can be controlled byrotating a rotational actuator (knob) 460. In one aspect, rotationalactuator 460 can control rotation of an end effector and/or catheterindependently of the control member. The control member, in one aspect,can be supported by the guide tube 26 that acts as the frame. Forexample, a portion of guide tube 26, including ring 461 can supportcontrol member 24 and allow relative rotational and/or longitudinalmovement of tool 40 (or catheter 25). Ring 461 can also act as a stop tolimit distal movement of tool 40. In another aspect, ring 461 can bedefined by a bite block or other apparatus mated with a patient.

FIG. 97 illustrates a capstan 416 for driving or assisting with drivingone or more degrees of freedom of tool 40. For example, when a userdrives a handle, the control wires can tighten around capstan 416 androtation of the capstan can augment force applied by the user. Inparticular, catheter actuation and/or articulation can be controlledwith or facilitated by the capstan. A variety of other mechanical forceor pull length multipliers could additionally or alternatively used,including, for example, pulleys, cams, and/or gears.

FIGS. 98A through 98C illustrates a drive link 418 that can reducestress on control cables or wires. In certain embodiments, when a firstcontrol wire is pulled, an opposing second control wire is compressed orpushed. Applying compressive forces on control wires can cause bucklingand/or wire fatigue. FIG. 98A illustrates an exemplary drive mechanismwithin control member 24 where pivoting of shaft 320 around axis 321 ina first direction applies compressive forces on one of control cables368 a, 368 b and a tensioning forces on the other of control cables 386a, 368 b. Similarly, rotating shaft 320 in a second, opposite directiontensions and compresses the other of cables 368 a, 368 b.

Drive link 418 allows control cables to engage only when pulled. Thus,the drive link can transmit force in one direction, but not in anopposite direction. In one aspect, the drive link mates with at leastone control wire, and in another aspect mates with first and secondcontrol wires. At least one of the first and second control wires canmovably mate with the drive link. In one exemplary aspect, the drivelink includes a channel that receives a cable terminal 419. When acompressive force is applied on a control wire, the cable terminal canmove within the channel. Conversely, then the first or second controlwire is pulled, the cable terminal of the first or second control wirecan engage the inner surface of the drive link and transmit forces tothe second of the first and second control wire.

In another aspect, the drive link can mate with a control wire at afirst end and mate with another portion of the control system at theother end. For example, the drive link can connect a shaft of thecontrol mechanism with a control wire.

FIGS. 99 and 100 illustrate mechanisms for adjusting the mechanicaladvantage of control member 24. In one aspect, mechanical advantage isadjusted by changing the location wherein control cables mate with acontrol mechanism. Where control cables are driven via movement of ashaft or a disk (as described above) the location of where the controlcables mate with the shaft or disk can be adjustable. Illustrated inFIG. 99, is a gear mechanism 420 a which engages cable mounting points.Rotating an adjustment knob can move a control cable toward or away froma pivot point or an axis of rotation of a control mechanism. Forexample, as described above (e.g., FIG. 44C), rotating disk 328 drivescontrol cables 368. The gear mechanism of FIG. 99 can be incorporatedinto the control member to move the location where control cables 368mate with disk 328. In another aspect, the ratio of input to outputmotion can be adjusted by adjusting the position of the cables towardand away from the center line or pivot point of a drive shaft or swashplate. FIG. 100 illustrates a control member that has an adjustablemechanical advantage that can be changed by moving termination points ofcontrol cables 368 along a slot 648.

FIG. 101 illustrates control member 24 with a control mechanism 422 forcontrolling multiple degrees of freedom via a single rod 650. Thecontrol mechanism consists of multiple, independently driven links 652a, 652 b that are manipulated via rod 650. While two links 652 a, 652 bare illustrated, three, four, or more than four links can surround adistal portion of rod 650. In the illustrated embodiment, rotation ofhandle 304 can pull rod 650 toward handle 304 and to the side (in thedirection of rotation). The transverse component of the rod's movementcauses rod 650 to engage one of links 652 a, 652 b without engaging theother of links 652 a, 652 b. Movement of link 652 a or 652 b causescorresponding movement of a control cable connected with the link.

In one aspect, control mechanism 422 is biased in the home position.When a user turns the control handle in the opposite direction orreleases the control handle, springs 654 can pull engaged link 652 a or652 b back towards its original position. Continued rotation of controlhandle 304 can engage opposing link 652 b or 652 a and drive a differentcontrol cable.

Rod 650 can include a distal driver 656 having a proximal surface shapedand sized to engage a corresponding surface on links 652 a, 652 b. Whenrod 650 is pulled, the proximal surface of distal driver 656 can inhibitslipping of driver 656 with respect to link 652 a or 652 b. The distalsurface of driver 656 can be configured to slip with respect to link 652a, 652 b. For example, the distal surface of driver 656 can include atapered or spherical shape that does not engage links 652 a, 652 b.

In another aspect, more than two links 652 surround driver 656. Wheremore than two links 652 a, 652 b are provided, rod 650 can drive twoadjacent links simultaneously to drive two degrees of freedomsimultaneously.

In another aspect, control mechanism 422 allows detachment of rod 650from drive mechanism 422. In use, the springs 654 can hold the links incontact with ball 656 and prevent detachment of rod 650 from controlmechanism 422. To detach rod 650, a user can pull the links away fromone another (against the force of springs 654) and/or remove springs654. Rod 650, including driver 656, can then be detached from links 652.In one aspect, detaching rod 650 allow detachment of catheter 25 from aportion of control member 24.

FIG. 102 illustrates a control member where instrument cables aredirectly attached to a user. For example, a user can manipulate a toolvia a glove 424. FIG. 103 illustrates a foot pedal 426 that can be usedin addition to, or as an alternative to, a hand controlled controlmember. For example, the foot pedal can control an additional degree offreedom of tool 40.

In some of the embodiments described herein, control member 24 is biasedin a home position. For example, resilient members (e.g., springs)within the control member can bias handle 304 in a neutral position.When a user releases the handle, springs apply forces to move the handletoward a home or neutral position. In another embodiment, control member24 can be configured to hold tool 40 in position after a user releaseshandle 304. For example, frictional resistance to movement or springscan prevent movement of handle 304 after a user moves and releases thehandle.

In another embodiment, tool 40 can be driven with mechanisms other thancontrol cables. For example, system 20 can employ a hydraulic-basedcontrol system. Alternatively, system 20 can employ muscle wires whereelectric current controls actuation of the surgical instruments.

FIG. 104 illustrates various locks for freezing or inhibiting movementof various degrees of freedom for system 20. In one aspect, (discussedabove) rail 224 and control member 24 can be locked to one another toprevent relative movement. In another aspect, as shown in FIG. 104,grooves on rail 224 can inhibit relative movement. When seated in thegrooves, longitudinal movement of control member 24 is inhibited withrespect to rail 224. In one aspect, the control member can be lifted toallow relative movement. Alternatively, the grooves can have a smallprofile and/or a shape that inhibits movement until a user appliessufficient force. Regardless, surface features on rail 224 can inhibitone degree of freedom (longitudinal movement) while permitting anotherdegree of movement (rotation).

In another embodiment, control member 24 can include locks that preventmovement of catheter 25 and/or the distal end effector. As shown in FIG.104, a ratchet mechanism 624 or ball and detent mechanism 626 caninhibit and/or prevent movement of at least one degree of freedom of thecontrol member. In one aspect, the locking mechanisms can preventmovement of handle 304. In another aspect, the locking mechanisms canselectively lock at least one degree of freedom of catheter actuation.In yet another aspect, the locking mechanisms can lock one degree offreedom while allowing movement and control of other degrees of freedomvia control member 24.

FIG. 105 illustrates another embodiment of control member 24 with alocking mechanism 434 that can tension control wires to prevent unwantedmovement of tool 40. In one aspect, locking mechanism 434 can preventmovement of control wires within the control member and thereby lock atleast one degree of freedom. In another aspect, locking mechanism 434can increase the force required to move at least one of the controlwires for articulating and/or actuating tool 40.

In another aspect, the control member can include a damping mechanism toreduce unwanted movement of tool 40 during manipulation of the controlmember. The damping can be passive and/or active on one or more degreesof freedom. In one aspect, a hydraulic damper or dash-pot can be matedwith at least one control wire within the control member to dampmovement of tool 40.

In another embodiment, a position or force sensor can be incorporatedinto system 20 to assist a user with controlling surgical instruments.In one aspect, a force gauge can measure the amount of force applied bya user for at least one degree of freedom. Maximum or current force canbe displayed for a user and/or tool movement can be restrained when athreshold force is reached.

As discussed above, system 20 can be a direct drive system such that auser's inputs to, or applied forces on, control member 24 aretransmitted to the distal end of tool 40. In one embodiment, system 20also provides a user with actual force feedback. As tool 40 contacts astructure, such as an anatomical structure, the user can feel the toolmaking contact with the structure and receive force and/or tactilefeedback. In one aspect, system 20 is adapted to maximize actual forcefeedback by minimizing unwanted damping. Exemplary structures forminimizing unwanted damping include friction reducing elements such as,for example, pulley bearings; low friction washers, bearings, brushings,liners, and coatings; minimizing bends in the working channels;increased stiffness in catheters; and gradual transitions betweenpassages within the guide tube. A stable ergonomic platform or frame canalso assist with force feedback by enabling deliberate movement/controlof tools 40 and minimizing distractive losses of energy. As an example,energy required to support a tool can result in distractive losses.Thus, the use of a frame to support tool 40 can reduce distractivelosses.

As mentioned above, a gas or liquid can be delivered to a body cavityvia guide tube 26. In one embodiment, the fluid is passed though a lumenwithin the control member and/or at least one of rails 224 a, 224 b. Asshown in FIG. 106, a opening 438 (e.g., luer fitting) can be positionedon the control member to provide an ingress and/or egress for fluid orsolids. The fluids or solids travel through a passageway 634 in controlmember 24 and into the guide tube and/or catheter 25 for egressproximate to the distal end of system 20. The luer fitting can also, oralternatively, be use to deliver a gas for insufflation or deflation. Inanother aspect, this lumen can be used to pass instruments to a surgicalsite.

Passageway 634 can extend through rail 224 in addition to, or as analternative to control member 24. For example, as illustrated in FIG.106, the passageway can extend through both control member 24 and rail224. In another aspect, rail 224 is spaced from control member 24 andthe rail includes a fitting for receiving ingress and/or egress offluid.

In another aspect, an electric current can be delivered to system 20through control member 24, guide tube 26, and/or rail 224. FIG. 107illustrates an electrified rail 440 for delivering power to a RFsurgical device. The rail can comprise an electrified pathway defined byan electrically conductive portion of the rail and/or defined by a wirehoused within a portion of the rail. In one aspect, energy can betransmitted from rail 244 to tool 40 via direct contact (electrifiedsurface of rail in electrical communication with electrical contact oncontrol member 24); via a wire extending between rail 224 and tool 40;and/or wirelessly (e.g., induction coil).

As mentioned above, system 20 can include an optical device, such as,optical device 28, for viewing a surgical site. The optical device caninclude a distal lens, a flexible elongate body, and proximal controlsfor articulating the distal end of the elongate body. In one aspect,optical device 28 includes controls and an articulating section.Alternatively, guide tube 26 is articulated to move the optical device.Regardless, a variety of optical devices, such as an endoscope,pediatric endoscope, and/or fiber-optic based device, can be used withsystem 20. In addition, the optical device can comprise a variety ofchips, such as, for example, CMOS and CCD based chips. In yet anotheraspect, optics can be incorporated into tools 40 a and/or 40 b. And instill another aspect, optics can be additionally, or alternatively,integrated into other system components, such as, for example, the guidetube.

Catheter and End Effector

As shown in FIG. 108, tool 40 generally includes a proximal controlmember 24, an elongate catheter body 25, and an end effector 502. FIG.109 illustrate a cut-away view of the mid-portion of catheter 25including an inner channel 520 for a bowden cable 522, which can includean outer sheath 524 and inner filament 526. In one aspect, more than oneinner channel 520 and/or one or more than one bowden cable 522 canextend through catheter 25 for control of end effector(s) 502. In yetanother embodiment, the bowden sheath is replaced with an insulatedmaterial (e.g., liner or insulated composite) and houses an electricallyconductive wire for transmitting electrosurgical energy.

Catheter 25 can further include tubular body 532 defining control wirelumens 528. Tubular body 532 can include the various features of workingchannel bodies 50 and/or inner and outer tubular bodies 46, 48,discussed above. In another aspect, tubular body 532 is a single,unitary body defining multiple control wire lumens 528. In one aspect,control wire lumens 528 can house control wires 530 for manipulating anarticulation section of tool 40. The number of control wires 530 andcontrol wire lumens 528 can be varied depending on the desired degreesof freedom of the tool 40 and the intended use of system 20.

Elongate body 500 can further comprise a wire or mesh layer 534positioned around tubular body 532. The properties of mesh layer 534 canbe varied to adjust the stiffness and/or strength of elongate body 500.The elongate body 500 can also include an outer sheath 536 to preventthe ingress of biological materials into tool 40. Outer sheath 536, inone aspect, is formed of a fluid impervious elastomeric or polymericmaterial.

In one aspect, tool 40 can be configured to provide at least one degreeof freedom, and in another aspect, can provide two, or more than two,degrees of freedom. For example, at least a portion tool 40 cancontrollably move up/down, side-to-side, laterally along the axis of theguide tube, rotationally around the axis of the guide tube, and/or canactuate the end effector. In one aspect, control cables extendingthrough catheter body 25 can move the end effector up/down,side-to-side, and can actuate end effector 502.

The distal end of tool 40 can, for example, include an articulatingsection 540 which provides an up/down and/or side-to-side articulation.As illustrated in FIG. 110, articulation section 540 can include meshlayer 534 and/or outer sheath 536 as discussed above with respect to themid-portion of elongate body 500. Within mesh layer 534, articulationsection 540 can comprise an articulating body 542 formed of a series oftube segments or rings (not illustrated). Control wires 530 can be matedto articulating body 542 to control movement of the articulating body542.

In addition, tool 40 can include a variety of alternative end effectors,for example, a grasper, scissors, tissue cutter, clamp, forcep,dissector, and/or other surgical tool that can open and close. Inanother aspect, the end effector is not configured to actuate. In stillanother aspect, the end effector is defined by a portion of the catheterbody and includes, for example, a blunt end or open lumen.

FIG. 111A illustrates one exemplary embodiment of end effector 502. Asshown, bowden cable 522 can be tensioned to close grasper 550.Similarly, FIG. 111B illustrates one exemplary embodiment of a needledriver 552 controlled by bowden cable 522. In yet another embodiment, acautery device can be used in place of the end effector. For example,FIG. 111C illustrates a hook cautery device 554. An energy source cancoupled to tool 40. For example, control member 24, frame 22, and/orrail 224, and can transmit energy to the distal hook cautery device 554.The variety of monopolar and bipolar cautery devices can be used withsystem 20. System 20 can include insulating materials to reduce thechance of stray electrical currents injuring the user and/or patient. Inone aspect, an insulating sheath 556 is positioned around an energydelivery wire 558.

Additional end effectors are also contemplated in addition to thoseillustrated in FIGS. 111A through 111C. For example, the end effectorcan include closure mechanisms such as clips, staples, loops and/orligator suturing devices. In addition, retrieval means, such as, forexample, snares, baskets, and/or loops can also be mated with system 20.In still another aspect, the end effector can be an exploration ortissue sampling device, such as, for example, optics, cytology brushes,forceps, coring devices, and/or fluid extraction and/or deliverydevices. In yet another aspect, instruments that aid in the patency of alumen or dilate an opening are contemplated. For example, the endeffector can be a balloon, patency brush, stent, fan retractor, and/orwire structures.

In yet another embodiment, tool 40 does not include an end effector. Forexample, the tool can include a blunt tip for exploration and/or forassisting another surgical instrument or end effector. In still anotherembodiment, tool 40 can include an open distal end for the delivery of atreatment fluid or solid and/or for collection of a bodily fluid ortissue sample. In one such aspect, catheter 25 can include an open lumenthat extends to the distal opening for delivery and/or collection of asubstance.

Described below are several alternative embodiments of tool 40.

FIG. 112 illustrates one aspect of an end effector 502 that includes aleaf spring 506 adapted to restrict motion of the end effector. In oneaspect, leaf spring 506, when position in end effector 502, prevents atleast one degree of freedom, such as, for example, motion in a directionparallel to a plane of the leaf spring. Leaf spring can be moved in andout of position via a pusher wire (not illustrated). While leaf spring506 is discussed with respect to an end effector, a leaf spring orsprings can be used throughout catheter 25 to inhibit movement of adegree of freedom.

FIG. 113 illustrates a mating plate 508 positioned proximate to theinterface of the catheter body 25 and end effector 502 of tool 40. Asdescribe above with respect to plate 63, mating plate 508 canfacilitated mating of control cables 510 with end effector 502.

As mentioned above, tool 40 can include control cables. In one aspect,at least one of the cables is a bowden-type cable. For example, abowden-type cable 512 can drive end effector 502, while the otherdegrees of freedom are manipulated by non-bowden-type wires.Alternatively, more than one degree of freedom could be controlled withbowden cables.

In another embodiment, tool 40 can have a variable length articulationsection. For example, as shown in FIG. 114, the length and/or positionof control cables 510 can be adjusted to control the length of thearticulation section of tool 40. In one aspect, cables 510 can bebowden-type cables and the length or position of the bowden cable sheathis adjusted to change the length of the articulation section.

Catheter body 25 can have a variety of alternative configurations. Inone aspect, the catheter body includes different properties along itsaxial length. For example, elongate body 500 can have materials withdifferent hardness along the length of the elongate body. In oneexample, catheter hardness varies along the length of the catheter. Inanother aspect, catheter hardness can vary in a transverse direction.FIG. 115 illustrates a softer durometer section 660 that extendsparallel to a harder durometer section 662. Variations in hardness canbe chosen to provide different bending characteristics.

In another aspect, a user can vary the hardness of catheter 25. FIG.116A illustrates catheter 25 having control wire lumens and stiffeninglumens 431. The stiffness of catheter 25 can be adjusted by injecting orremoving a material (e.g., a fluid) into the stiffening lumens 431. Inone aspect, catheter 25 includes opposed stiffening lumens 431 thatpermit a user to adjust the bending characteristics of the catheter. Forexample, one side of the catheter can be increased in stiffness. Inanother aspect, different segment of the catheter along its length canhave different stiffening lumens to allow stiffness variability alongthe length of the catheter.

In one aspect, a user can inject a stiffening fluid. In another aspect,the stiffening lumens can receive a stiffening rod or rods. For example,catheter 25 can be provided with a set of stiffening rods havingdifferent stiffness. A user can select a stiffening rod of a desiredstiffness and insert the selected rod to adjust catheter properties. Thestiffening rods can also have different lengths or varying stiffnessalong their length to allow adjustment of stiffness along the length ofthe catheter.

In another embodiment, a magnetic rheological fluid within catheter 25can stiffen and/or lock the catheter. FIG. 116B illustrates a chamber762 for receiving magnetic rheological fluid and a magnet 764 that canapply a magnetic field on the fluid within chamber 762 to stiffen thecatheter. In one aspect, chamber 762 extends along a length of catheter25. When a magnetic field is applied, the stiffened fluid can preventside-to-side and/or up/down movement of the catheter.

FIG. 117 illustrates catheter tips have a tip wider 432 than the body ofcatheter 25. The wide tip can provide greater bend strength by allowingincreased separation of pull wires. In one aspect, catheter 25 of FIG.117 is used with a guide tube having a working lumen with increaseddiameter in a distal portion thereof. The distal section of the workingchannel can be sized and shaped for receipt of the wide tip. In oneaspect, the wide tip is larger than a proximal portion of the workinglumen. The catheter can be placed within the working lumen prior toinsertion of the guide tube into a patient.

In still another embodiment, the elongate body 500 of tool 40 can havemore than three degrees of freedom. FIG. 118 illustrates body 500 havingmultiple body segments and multiple degrees of freedom, including, forexample additional rotation, longitudinal, pivotal, and bending degreesof freedom. In one aspect, tool 40 can include more than onearticulating or bending section along its length. In another aspect afirst catheter segment 500 a can rotate with respect to a secondcatheter segment 500 b. In another aspect, catheter body 500 can includetelescoping segments. For example, catheter segments 500 a, 500 b, 500 ccan be telescoping.

In another example of a catheter having additional degrees of freedom,catheter 25 can have two longitudinally separated articulation sections.Thus, the catheter can have a “wrist” and an “elbow.” The wrist andelbow can permit the tool to form a s-curve.

To assist with determining the location of, or degree of movement of,the end effector 502, a portion of tool 40 can include markings. FIG.119 illustrates tool 40 having markings 516 for determining the amountof relative movement between tool 40 and another portion of system 20.In one aspect, the indicia allow a user to determine the rotationaland/or longitudinal position of the catheter with respect to the guidetube, frame, rails, patient, and/or another point of reference.

A variety of catheter body structures can be used with system 20. FIGS.120A and 120B illustrate one exemplary embodiment of tool 40 having amain body 700 and a distal articulating section 702. Main body 700 canbe comprised of a semi-flexible extrusion 704 such as nylon, PTFE, orthe equivalent. In one aspect, the main body can include at least onelumen for a bowden cable. For example, a bowden cable can extend througha central lumen within main body 700. Additional control cables, such asbowden cables or pull wires, can extend through the central lumen and/orbe housed in separate lumens. In one aspect, multiple lumens, such as,for example, four lumens, are provided for multiple bowden cables, suchas, for example, four bowden cables.

Alternatively, or additionally, the catheter body can have a variety ofdifferent configurations depending on the intended use of tool 40. Forexample, instead of mating with an end effector, body 700 can have anopen lumen for delivering a separate instrument or therapeuticsubstance. In another aspect, the body can be formed of an electricallyinsulative material and/or include an insulative liner to allow thetransmission of electrosurgical energy to an end effector.

The articulation section 702 can include a softer or lower durometerextrusion. The articulation-section extrusion can have a similararrangement of lumens as the body extrusion. For example, thearticulation section 702 can include a central longitudinal opening forreceiving a bowden cable.

Tool 40 can include a transition region where the catheter stiffnesschanges between harder and softer sections. As shown in FIG. 120A, aportion of main body 700 can extend into the articulation section. Inparticular, a extension member 710 of the main body can extend into alumen of the articulation section. Extension member 710 can have a sizeand shape corresponding to the inner lumen of the articulation section.In use, the extension member can stiffen the proximal end of thearticulation section to provide a gradual transition between the hardermain body and softer articulation section. In one aspect, the extensionportion has varying flexibility such that at its proximal end theextension portion has a stiffer configuration and less stiffconfiguration at its distal end.

As shown in FIGS. 120A, 121A, and 121B, tool 40 can include a thrustplate 706 positioned between the main body and articulation section. Inone aspect, the thrust plate can include holes or slots 708 for strandsto extend through. The holes can be sized to allow the inner strand of abowden cable to pass therethrough. Conversely, the outer casing of thebowden cables are prevented from extending distally beyond the thrustplate. For example, the outer casings can mate with the thrust plateand/or the thrust plate holes can be sized to prevent the passage of thebowden casings therethrough. In one aspect, as shown in FIG. 121B, thethrust plate can include recessed areas around the holes 708 to receivethe bowden cable casings.

In one aspect, the thrust plate can be formed by a single-piece thrustplate body. In another aspect, thrust plate 706 is defined by a multiplepiece structure. For example, FIG. 120A illustrates a two-piece thrustplate. Together, the two-pieces define the desired shape of thrust plate706.

In another aspect, thrust plate 706 includes a central opening 711 sizedand shaped to receive extension member 710 of main body 700. Theextension member can pass through central opening 711 and into acorresponding lumen within articulation section 702.

FIGS. 122A through 126 illustrate yet another embodiment of a tool foruse with the systems described herein. Instead of an end effector matedwith tool 40 as described above, in another embodiment tool 40 iscomposed of two independent bodies. As illustrated in FIG. 122A, tool 40can include a first tool member 41 a and a second tool member 41 b.Together, tool members 41 a and 41 b can provide the same functionalityas tool 40 described above. However, two-part tool 40 allows a user toremoved and replace tool member 41 b to change distal end effectors. Inaddition, the two-part tool can provide additional degrees of freedom.

FIGS. 123A and 123B illustrate catheter body 25′ defined by a firstouter body 800 of tool member 41 a and a second inner body 802 of toolmember 41 b. The outer body 800 can have an open inner lumen thatextends from control member 24 to the distal end of the tool. Secondinner body 802 can include an elongate member and end effectorconfigured to pass through the outer body. In use, the inner body can bedirected through the outer body so that the end effector of the innerbody extends out of the distal end of the outer body. The inner andouter bodies can work together and act as a single-body tool.

The outer body can control up to four degrees of freedom, while theinner body can have at least one degree of freedom. For example, theouter body can control left/right, up/down, longitudinal movement,and/or rotational movement as described above with respect to tools 40.The additional degree of freedom provided by the inner body can beactuation of the end effector.

In one aspect, the inner and outer bodies 800, 802 can mate with eachother with such that inner body 802 and end effector 502 move in unisonwith outer body 800. When the inner and outer bodies are mated with oneanother, bending or articulating outer body 800 can cause the inner body802 to bend without end effector 502 of the inner body movinglongitudinally with respect to the outer body. Additionally, oralternatively, when the inner and outer bodies are mated, rotationalmovement of the outer and/or inner body is transmitted to the other ofthe outer and inner body. For example, when the outer body rotates, theend effector 502 of inner body 802 can move in unison with the outerbody.

In one aspect, the distal ends of the inner and outer bodies can matewith an interference fit when the inner body is positioned within theouter body. In addition, or alternatively, the inner and outer bodiescan mate with a threaded connection, twist lock, snap-fit, taper lock,or other mechanical or frictional engagement. In one aspect, the innerand outer bodies mate at the distal end of tool 40 proximate to endeffector 502. In another aspect, the inner and outer body can mate aseveral locations along the length of tool 40. In one aspect, mating theinner and outer bodies 800, 802 prevents relative translational and/orrotational movement of the distal ends of the inner and outer bodies.

In another embodiment, the inner and outer bodies can include matingfeatures that allow one of rotational and translational movement whilepreventing the other of rotational and translational movement. Forexample, longitudinal grooves and corresponding recess on the inner andouter bodies can inhibit relative rotational movement while allowingrelative longitudinal movement. In another aspect, the mating featuresof the inner and outer body can be adapted to allow rotation whilepreventing longitudinal movement. For example, a rotatable snap fit caninhibit relative longitudinal movement of the first and second bodies.

The mating features of tool 40 can act as a stop so that when the innerand outer bodies are mated, distal movement to the inner body, withrespect to the outer body, is prevented. The mating features cantherefore control the distance which the inner body (and particularlythe end effector) extends beyond the outer body. In one aspect, thedistal end of inner body 802 includes a first diameter and a second,larger diameter. The outer body 800 can have stop defined by an innerdiameter that allows passage of the first diameter by prevents passageof the second, larger diameter. In one aspect, the stop is positioned tosuch that further distal movement of the inner body is prevented afterend effector 502 passes through a distal opening 503.

In another aspect, illustrated in FIGS. 123C and 123D, a portion ofinner body 802 comprising an articulation section 804, can extend beyonda distal end 810 of outer body 800. Articulation section 804 can provideone or more than one additional degree of freedom to tool 40 and allow,for example, left/right and/or up/down movement. Other additional, oralternative degrees of freedom for the inner body with respect of theouter body can include longitudinal movement and/or a pre-curved body.

In another aspect, the end effector can rotate with respect to outerbody 800 of tool 41 a. For example, the inner body can be fixedly matedwith the end effector and rotation of the end effector can be driven byrotating the inner body. Alternatively, the end effector can be rotatedindependently of the inner and outer bodies. In another aspect, rotationof the end effector can be controllably locked with respect to the outerbody. For example, after rotating the end effector into a desiredconfiguration via rotation of the inner body, the end effector can belocked with respect to the inner a

With respect to FIG. 122A, the inner body 802 can extend to a proximalcontroller 714 for controlling end effector 502 and/or articulationsection 804. In one aspect, inner body 802 passes through proximalcontroller 24 of tool member 41 a. For example, control member 24 caninclude a proximal aperture for receiving inner body 802.

Proximal controller 714 can, in one aspect, mate with a portion ofcontrol member 24. As illustrated in FIGS. 122A and 122B, controller 714can be a pull or push ring for manipulating with a user's finger. Theproximal controller 714 can mate with handle 304 of tool member 41 a toallow a user to control both the inner and outer bodies 802, 800 with asingle hand.

In another embodiment, a user can articulate the inner body viamanipulation of outer body control member 24. As illustrated in FIG.124, the inner body, and particularly controller 714 of tool member 41b, can mate with control member 24 of tool member 41 a. A user can drivecontroller 714 via manipulation of control member handle 304. In oneexemplary aspect, the proximal end of the inner body 802 can mate with aspool mount 812 on control member 24 which is articulated via thetrigger on the handle 304 of the control member. It should beappreciated that the spool and/or thumb ring can be driven via movementof handle 304 or trigger 306.

In one embodiment, the outer body can work with a variety of differentinner bodies to allow a clinician to quickly change the end effectorassociated with tool 40. When a new end effector is desired, a user canremove and replace the inner body with a different inner body having adifferent end effector.

In another embodiment of a two-part tool, the outer body can include anend effector while the inner body drives articulation of the combinedinner and outer bodies. FIGS. 125A through 125C illustrate exemplaryaspects of this configuration. As illustrated in FIG. 125A, outer body800 includes a lumen 770 sized and shaped to receive the inner body. Inone aspect, lumen 770 has a closed distal end and outer body 800includes end effector 502. Inner body 802 can have a size and shapecorresponding to at least a portion of lumen 770. In addition, innerbody 802 can have an articulation section 772 for driving articulationof tool 40. For example, pull wires 774 can extend to articulationsection 772 for driving the inner body. When positioned within the outerbody, articulation of the inner body drives the outer body.

In one aspect, illustrated in FIG. 125A, the inner body can include acontrol wire 776 for driving the end effector of the outer body. Controlwire 776 can mate with an end effector control wire 778 when the innerand outer bodies are mated. When force is applied on control wire 776,the force can be transmitted to control wire 778 for actuating endeffector 502. One skilled in the art will appreciate that a variety ofmechanical interlocks and/or frictional engagements can be used to matecontrol wires 776, 778. In one aspect, the distal end of control wire776 can include a mating feature for receipt within a control wire 778.Control wire 776 is first advanced into control wire 778. The proximalend of control wire 778 can then be squeezed or compressed to preventwithdrawal of control wire 776 from control wire 778. In one aspect,moving control wire 778 of outer body 800 into inner body 802 cancompress control wire 778 and lock control wire 778 with inner body 802.

In another aspect, instead of control wires for end effector 502extending through inner body 802, a control wire or wires can extendingthrough or along the outer body 800. As illustrated in FIG. 125B,control wires 778 a, 778 b extend through lumen 770. Alternatively, alumen within the wall of outer body member 800 can house control wires778 a, 778 b.

In one aspect, two control wires 778 a, 778 b are provided for actuatingend effector 502. In use, wires 778 a, 778 b are pulled in unison toavoid unwanted articulation of tool 40. In one aspect, control wires 778a, 778 b mate with a shaft 782. User input forces can be deliveredthrough control wires 778 a, 778 b to shaft 782 such that pulling oncontrol wires 778 a, 778 b actuates end effector 502. Outer body member800 can include a chamber 784 that permits movement of shaft 782therein.

While articulation of tool 40 is illustrated a articulated via controlwires, other articulating mechanisms are also contemplated. In oneaspect, illustrated in FIG. 125C, the inner body 802 can include apre-shaped body. When the inner and outer body members exit a guide tube26, and are not longer constrained by the guide tube, the pre-shapedinner body 802 can bend tool 40. In one aspect, the inner body 802 canbe rotated within the outer body to allow tool 40 to bend in differentdirections.

The inner and outer bodies 802, 800 illustrated in FIGS. 125A through125C can mate or dock with one another when inner body 802 is positionedwithin lumen 770 within the outer body. In one aspect, illustrated inFIG. 125B, the inner and outer bodies can mate with a snap-fit. When theinner body is mated the snap fit can provide a user with tactilefeedback and indicate proper docking of the inner and outer bodies. Oneskilled in the art will appreciate that a variety of additional oralternative mating mechanisms can permit docking of the inner and outerbodies.

The various embodiments and the various components of system 20described herein can be disposable or reusable. In one embodiment, atleast some of the components of system 20 designed for contact withtissue can be disposable. For example, guide tube 26 and/or tools 40 a,40 b can be disposable. In another aspect, a portion of tools 40 a, 40b, such as catheter 25 a, 25 b and/or end effectors 502 can bedisposable. In yet another embodiment, for example, where rails 224 a,224 b are fixedly mated with control members 24 a, 24 b, the rails canalso be disposable. Conversely, components such as frame 22 and/or rails224 a, 224 b can be reusable.

Where sterile system components are necessary or desired, the system caninclude seals, shrouds, drapes, and/or bags to protect sterility. Forexample, where the working and/or main lumen of the guide tube ismaintained is a sterile condition, a shroud, drape, and/or seal could beplaced at the distal and/or proximal entrances to the guide tubepassageways. FIG. 126 illustrates a bag or sheath 715 placed over thedistal portion of tool 40 to maintain sterility. As described above, aportion of the tool, such as catheter 25, can be detachably mated withtool 40. In use, the sterile catheter can be attached to the reusable ornon-sterile control member 24. Similarly, as illustrated in FIG. 127, abag or sheath can be mated with the distal portion of guide tube 26. Thenon-sterile and sterile portions of the guide tube can be mated prior touse. FIG. 128 illustrates a shroud 660 at the entrance 38 to workinglumen 44 to help protect the sterility of guide tube 26. FIG. 129illustrates a reusable control member and catheter with a detachable,end effector. FIG. 130 illustrates tool 40 with a disposable inner bodyand a reusable outer body.

Further described herein are methods of using system 20. In oneembodiment, guide tube 26 is delivered through a natural body orifice toa surgical site. At least one optical device, such as a pediatricendoscope, is then delivered through working channel 42. In addition, atleast one tool 40 is delivered through one of the working channels. Theproximal end of tool 40, e.g., control member 24, can be attached toframe 22. In one aspect, control member 24 is mated with rail 224 suchthat the tool 40 can be moved longitudinally on rail 224 and/or rotatedabout rail 224.

In one aspect, system 20 provides at least two degrees of freedom to thedistal end of tool 40 which is controlled by moving control member 24 onrail 224. For example, a end effector can be rotated and movedlongitudinally by manipulating control member 24.

In another aspect, additional degrees of freedom are provided by anarticulation section of guide tube 26. For example, guide tube 26 can bymoved up/down and/or side-to-side via controls 30. Thus, system 20 canprovide three or more than three degrees of freedom to the end effector.

In another aspect additional degrees of freedom are provided by tool 40.For example, control member 24 can move the distal end of tool 40up/down and/or side-to-side by manipulating handle 304. In addition,handle 304 can control actuation of end effector to grasp and/or cuttissue. Further degrees of freedom can be added to the tool and/or guidetube with the use of additional articulation sections and/or pre-curvedsegments.

In one embodiment, the various degrees of freedom provided by controlmember 24, rails 224, and/or guide tube 26 allow a surgeon to movetissue, grasp tissue, cut tissue, suture tissue, and/or explore ananatomical structure. In another embodiment, system 20 includes twotools 40 each having multiple degrees of freedom. In particular, system20 can provide sufficient freedom of movement to allow tools 40 to worktogether while viewed by a surgeon. Thus, unlike conventional systems,the system described herein allows surgeons to perform procedures thatrequire at least partially independent control of two tools andsufficient freedom of movement to allow the tools to work together.

In one embodiment, the degrees of freedom system 20 provides to the endeffectors and the ability to simultaneously control those degrees offreedom, allows a clinician to tie knots and/or suture at a distance.Further described herein is a method of knot tying at a distance. In oneaspect, knot tying is performed via a system including a flexible guidetube and/or flexible tools. Such a system can allow knot tying at adistance where system 20 is inserted through a natural orifice.

A system 20 having any or all of the various features described abovecan be provided. In one aspect, as illustrated in FIG. 131A, a first andsecond tool 40 a, 40 b a placed proximate to a target site, such as, forexample, a surgical site. In one aspect, knot tying is part of asuturing or tissue apposition procedure. A suture, wire, or filament 900is grasped with a first tool. A variety of end effectors can be matedwith tool 40 a, 40 b for grasping and/or manipulating the suture. In oneaspect, at least one of the end effectors is a forceps.

With the suture held with a first end effector 502 a, the first andsecond tools are manipulated, via first and second proximal controllers,to wrap the suture around the second tool 40 b (i.e., around a seconddistal end effector 502 b). In one aspect, first distal end effector 502a remains stationary and the second distal end effector 502 b is movedaround the suture to form a loop. For example, as shown in FIG. 131B,the tip of second distal end effector 502 b is maneuvered around thesuture. Alternatively, the second distal end effector can remainstationary and the suture can be wrapped around the second distal endeffector by movement of the first distal end effector. In yet anotheraspect, the user can move by the first and second distal end effectorrelative to one another to form a loop around the second distal endeffector.

Once a loop is formed about second distal end effector 502 b, a user canmove the second tool 40 b into position to grasp the suture with thesecond distal end effector 502 b. As shown in FIG. 131C, second distalend effector 502 b can be translated to move forward and actuated toopen the forceps. With the suture grasped by the first and second endeffectors, the user can translate (pull on) the second tool to move thesecond distal end effector through the loop and form a single flat knotas shown in FIG. 131D.

With the first flat knot in place, a second knot can be formed tocomplete a square knot. As illustrated in FIGS. 131E through 131J, theprocedure describe above can be repeated with the first and seconddistal end effectors taking opposite roles and the loop of suture beingwrapped in the opposite direction.

As part of the knot tying procedure, tools 40 a, 40 b allow a user toindependently control movement or hold the position of the first andsecond distal end effectors. In one aspect, the first and second tools,via first and second proximal control members, are translated (movedforward/back), rotated (torqued), articulated (moved up/down and/orleft/right), and actuated (forceps are opened closed). Each of thesemovements can be performed independently for the first and second tools.In addition, a user can control two or more of these movementssimultaneously.

Provided below are exemplary classes of procedures and specificprocedures which the system described herein can perform.

Cardiovascular

Revascularization

-   -   Drilling    -   Bypass    -   Shunts

Valves (replacement & repair)

Left Atrial Appendage (closure, occlusion or removal for strokeprevention)

Left Ventricular Reduction

Atrial and Septal Defects

Aneurysm Repair

Vascular Grafting

Endarterectomy

Percutaneous Transluminal Coronary Angioplasty (PTCA)

Percutaneous Transluminal Angioplasty (PTA)

Vascular Stenting

-   -   Primary Placement    -   Restenosis Therapy

Vessel Harvest

-   -   Saphenous Vein Graft    -   Internal Mammary Artery

Cardiac Assist Devices

Electrophysiology (mapping & ablation)

-   -   Intraluminal    -   Extraluminal        Radiology

Non-Vascular Radiology

Pulmonary/ENT

Lung Volume Reduction

Lung Cancer Therapy

Esphagectomy

Larynx Surgery

Tonsils

Apnea

Nasal/Sinuses

Otolaryngology

Neurology

Tumor Therapy

Hydrocephalus

Orthopedics

Gynecology

Hysteroscopy

Hysterectomy

Fertility

-   -   Improvement    -   Sterilization

Myomectomy

Endometriosis

General Surgery

Cholecystectomy

Hernia

-   -   Abdominal    -   Diaphragm

Adhesions

Gastrointestinal

Bleeding

Tissue Resection

GERD

Barret's Esophagus

Obesity

Colon Surgery

Urology

Kidney Stones

Bladder Cancer

Incontinence

Ureteral Reimplantation

Prostate

Provided below is an exemplary list of access points for the systemsdescribed herein

Trans-oral

Trans-anal

Trans-vaginal

Percutaneous

Laparoscopic

Thorascopic

To the circulatory system

Trans-nasal

Trans-uretheral

What is claimed is:
 1. A drive system comprising: at least one toolcomprising: an elongate body extending between a proximal end and adistal end; and a single controller including a body and a handle forreceiving a force applied to the controller by a user and mechanicallytransmitting the force to an articulation section, wherein the handle iscoupled to the body of the controller by a shaft and is rotatablerelative to the body of the controller about at least two differentaxes; a guide tube comprising a first lumen configured for passage ofthe elongate body therethrough and a second lumen, wherein the first andsecond lumens diverge at a distal end of the guide tube; and a framecoupled to the at least one tool such that the controller is moveablerelative to the frame to control at least two degrees of freedom of thetool with respect to the frame and to direct at least one degree offreedom of the distal end of the tool; wherein the controller is fixedlyattached to a plurality of control members, the plurality of controlmembers and the controller being translatable along a longitudinal axisof the elongate body.
 2. The system of claim 1, wherein the distal endof the tool includes an end effector, and wherein the controller isconfigured to direct at least two degrees of freedom of the distal endvia the articulation section and to control an additional degree offreedom of the distal end by actuation of the end effector.
 3. Thesystem of claim 1, wherein the controller is configured tosimultaneously control movement of the articulation section and movementof the tool relative to the frame.
 4. The system of claim 1, wherein theat least one degree of freedom of the distal end of the tool includesmovement of the articulation section.
 5. The system of claim 1, whereinthe frame is fixedly located with respect to a patient.
 6. The system ofclaim 1, further comprising an optical device.
 7. The system of claim 1,wherein the at least one tool is rotatable about the longitudinal axisof the elongate body relative to the frame.
 8. The system of claim 7,wherein the controller is rotatable about the longitudinal axis of theelongate body.
 9. The system of claim 1, wherein the controller isfixedly attached to the elongate body, and wherein the at least one toolis translatable along the longitudinal axis of the elongate body. 10.The system of claim 1, further comprising a rail that movably mates theat least one tool and the frame, wherein the rail constrains movement ofthe controller with respect to the frame to movement along axes parallelto a longitudinal axis of the rail.
 11. The system of claim 10, whereinthe rail is parallel to the longitudinal axis of the elongate body ofthe tool.
 12. The system of claim 10, wherein the rail includes at leastone of a proximal stop and a distal stop, configured to limitlongitudinal movement of the controller.
 13. The system of claim 10,further comprising an electrically conductive pathway extending betweenthe rail and the controller.
 14. The system of claim 10, furthercomprising indicia on at least one of the rail, the frame, and thecontroller for indicating the relative position or orientation of thedistal end of the tool.
 15. The system of claim 10, wherein the rail hasa non-linear shape.
 16. The system of claim 10, wherein the rail isfixedly mated to the at least one tool.
 17. The system of claim 10,wherein the controller is configured to rotate about the longitudinalaxis of the rail.
 18. The system of claim 10, wherein the rail ismoveably coupled to the elongate body of the at least one tool.
 19. Thesystem of claim 1, further comprising a lock for inhibiting movement ofthe articulation section of the tool when engaged.
 20. The drive systemof claim 1, wherein the at least one tool includes an end effector, andwherein the plurality of control members mechanically couples thecontroller to at least one of the articulation section or the endeffector to mechanically transmit the force to the articulation sectionor the end effector.
 21. The drive system of claim 20, wherein theplurality of control members directly couples the controller to thearticulation section.
 22. The drive system of claim 21, wherein theplurality of control members are disposed within the elongate body, eachcontrol member of the plurality of control members having a first endcoupled to the controller and a second end coupled to the articulationsection or the end effector.
 23. The drive system of claim 20, whereineach control member of the plurality of control members includes adistal region, a proximal region, and a detachable coupler locatedbetween the distal region and the proximal region.
 24. The drive systemof claim 20, wherein at least part of a control member of the pluralityof control members includes at least one of a wire, a strand, a leafspring, a cable, a bowden cable, an oversheath, and a ribbon.
 25. Thedrive system of claim 20, wherein at least three control membersmechanically couple the controller to the articulation section.
 26. Thedrive system of claim 20, further including a mechanical forcemultiplier configured to engage the plurality of control members. 27.The system of claim 1, wherein the at least two different axes areorthogonal to each other.
 28. The system of claim 27, wherein the handleis coupled to the body of the controller via a trunion.
 29. The systemof claim 1, wherein the controller is moveable relative to the frameabout a first rotational axis, and the handle is moveable relative tothe body of the controller about two generally orthogonal axes that areboth generally orthogonal to the first rotational axis.
 30. The systemof claim 1, wherein the shaft is fixedly attached to the handle androtatably coupled to the body of the controller, such that the handle isrotatable about an axis defined by the shaft.
 31. A drive systemcomprising: at least one tool including: an elongate body extendingbetween a proximal end and a distal end; and a single controllerconfigured to receive a force and mechanically transmit the force to anarticulation section of the tool via at least one control member of aplurality of control members coupled to the controller and to thearticulation section, wherein the controller is fixedly attached to theplurality of control members within the elongate body, the plurality ofcontrol members and the controller being translatable along alongitudinal axis of the elongate body, and wherein the controllerincludes a handle coupled to a body of the controller by a shaft, suchthat the handle is rotatable relative to the body of the controllerabout at least two different axes; a frame coupled to the at least onetool such that the controller of the at least one tool is moveablerelative to the frame to control at least two degrees of freedom of thetool with respect to the frame and to control at least one degree offreedom of the distal end of the tool; and a guide tube comprising afirst lumen configured for passage of the elongate body therethrough anda second lumen, wherein the first and second lumens diverge at a distalend of the guide tube.
 32. The system of claim 31, wherein the guidetube includes an articulation section.
 33. The system of claim 32,wherein the articulation section of the guide tube is controlled by atleast one control knob located at a proximal end of the guide tube. 34.The system of claim 33, wherein the at least one control knob includestwo coaxial control knobs.
 35. The system of claim 31, further includingan optical device configured for passage within the at least one lumenof the guide tube.
 36. The system of claim 31, wherein the guide tube isremovably coupled to the frame.
 37. The system of claim 31, wherein eachof the first lumen and the second lumen, extends from a proximal end ofthe guide tube to the distal end of the guide tube.
 38. The system ofclaim 37, wherein the at least one tool is a first tool configured forpassage through the first lumen of the guide tube, the system furthercomprising a second tool configured for passage through the second lumenof the guide tube, wherein the first tool is rotationally coupled to theframe via a first rail and the second tool is rotationally coupled tothe frame via a second rail different from the first rail.
 39. A drivesystem comprising: a tool, including: an elongate body extending betweena proximal end and a distal end; and a single controller including ahandle coupled to a body of the controller by a shaft, the handlerotatable relative to the body of the controller about at least twodifferent axes, wherein the controller is fixedly attached to aplurality of control members, the plurality of control members and thecontroller being translatable along a longitudinal axis of the elongatebody, and wherein the body of the controller is fixedly attached to theelongate body and the handle is configured to transmit a first force toan end effector via at least one control member of the plurality ofcontrol members coupled to the controller and to the end effector, andconfigured to transmit a second force to an articulation section; aguide tube comprising a first lumen configured for passage of theelongate body therethrough and a second lumen, wherein the first andsecond lumens diverge at a distal end of the guide tube; a frame; and arail movably mating the tool and the frame.
 40. The system of claim 39,wherein the handle includes a trigger coupled to at least one controlmember of the plurality of control members.
 41. The system of claim 40,wherein the trigger is rotatably coupled to the handle.
 42. The systemof claim 41, wherein the trigger is lockable.
 43. The system of claim39, wherein rotation of the handle relative to the body of thecontroller about the at least two different axes controls at least twodegrees of freedom of the distal end of the tool.
 44. The system ofclaim 39, wherein the proximal end of the elongate body is fixedlyattached to a distal end of the body of the controller.
 45. The systemof claim 39, wherein the elongate body includes a rigid proximal portionfixedly attached to the body of the controller.
 46. The system of claim39, wherein the rail constrains movement of the controller with respectto the frame to movement along axes parallel to a longitudinal axis ofthe rail, and wherein the frame includes a tubular structure configuredto receive the rail.
 47. The system of claim 39, wherein the frame has afixed location relative to a patient, and wherein the tool is moveablerelative to the frame to permit movement of the tool to control at leasttwo degrees of freedom of the distal end of the tool.
 48. A drive systemcomprising: at least one tool comprising: an elongate body extendingbetween a proximal end and a distal end; and a single controllerincluding a body and a handle for receiving a force applied to thehandle by a user and mechanically transmitting the force to anarticulation section, wherein the handle is coupled to the body of thecontroller via a shaft, the handle being rotatable about an axis definedby the shaft and rotatable relative to the body of the controller aboutat least one additional axis; a guide tube comprising a first lumenconfigured for passage of the elongate body therethrough and a secondlumen, wherein the first and second lumens diverge at a distal end ofthe guide tube; and a frame coupled to the at least one tool such thatthe controller is moveable relative to the frame to allow the user tocontrol at least two degrees of freedom of the tool with respect to theframe and to direct at least one degree of freedom of the distal end ofthe tool; wherein the controller is fixedly attached to a plurality ofcontrol members within the elongate body, the plurality of controlmembers and the controller being translatable along a longitudinal axisof the elongate body.
 49. A drive system comprising: at least one toolincluding: an elongate body extending between a proximal end and adistal end; and a single controller coupled to the elongate body, thecontroller including a body and a handle configured to receive a forceapplied to the controller and mechanically transmit the force to anarticulation section via at least one control member of a plurality ofcontrol members coupled to the controller and to the articulationsection, wherein the controller is fixedly attached to the plurality ofcontrol members within the elongate body, the plurality of controlmembers and the controller being translatable along a longitudinal axisof the elongate body, and wherein the handle is coupled to the body ofthe controller by a shaft and is rotatable relative to the body of thecontroller about at least two different axes; and a frame configured tomate with the at least one tool such that the controller of the at leastone tool is moveable relative to the frame to allow the user to controlat least two degrees of freedom of the tool with respect to the frameand to control at least one degree of freedom of the distal end of thetool; and a guide tube comprising a first lumen configured for passageof the elongate body therethrough and a second lumen, wherein the firstand second lumens diverge at a distal end of the guide tube.
 50. Thesystem of claim 49, wherein the guide tube is removably coupled to thetool.
 51. A drive system comprising: a tool, including: an elongate bodyextending between a proximal end and a distal end; and a singlecontroller including a handle coupled to a body of the controller by ashaft, the handle being rotatable relative to the body of the controllerabout at least two different axes, wherein the controller is fixedlyattached to the elongate body, and the handle is configured to transmita first force to an end effector and a second force to an articulationsection, the first and second forces being applied directly to thehandle by a user and transmitted to the end effector and thearticulation section via a plurality of control members, wherein thecontroller is fixedly attached to the plurality of control members, theplurality of control members and the controller being translatable alonga longitudinal axis of the elongate body; a guide tube comprising afirst lumen configured for passage of the elongate body therethrough anda second lumen, wherein the first and second lumens diverge at a distalend of the guide tube; and a frame, wherein the tool is moveably matedrelative to the frame to permit movement of the tool in at least tworotational directions and at least two longitudinal directions relativeto the frame to control at least two degrees of freedom of the distalend of the tool relative to the patient.
 52. The system of claim 51,wherein the handle is configured to receive a palmar surface of a handof the user.
 53. The system of claim 51, wherein the handle isconfigured to receive a finger of the user.